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0-5 years of experience
As part of a quality assurance team, developed, refined and implemented practices and procedures with the manufacturing and production department, accommodating rapid business growth of 70% annually for 5 consecutive years
- Reduced production costs by $2.5 million by implementing automated test practices and improving manufacturing practices for product revisions and upgrades, resulting in fewer product recalls
- Streamlined shipping protocols, significantly reducing shipping costs
- Successfully realized ISO 2000 certification as part of the Quality Assurance team.
- Initiated an RFP for computer hardware and successfully negotiated a contract resulting in corporate savings in excess of $1 million dollars
- Negotiated all test equipment leases
0-5 years of experience
Performed site visits and audited finance and attendance records of all licensed family homes, individual providers, and daycare centers receiving childcare subsidy payments from the State of Washington as part of a team of nine Auditors and Quality Assurance Specialists.
- Examined records and interview childcare providers and workers to ensure recording of transactions and compliance with laws and regulations.
- Collected and analyzed data to detect extravagance, fraud, or non-compliance with laws, regulations, and management policies.
- Prepared detailed reports on audit findings.
- Investigated and identified high risk practices, performed random audits, recovered overpayments, conducted payouts of underpayments, and referred suspected fraud for investigation by state officials.
- Reviewed and audited child care attendance records gathered by eight team members to ensure quality control and submitted reviewed records to the State Auditor’s Office.
- Ensured the accountability of the child care subsidy program that issued between $400 and $50K in monthly payments to individual and facility providers.
6-10 years of experience
Listened to sales calls throughout the day and scored the calls based on set parameters for process adherence
- Improved sales conversion rates 64% by developing scripted rebuttals for agents to use when facing objections
- Managed a team of 7 specialists, responsible for auditing calls for sales teams totaling 250-300 agents
- Improved team productivity 60%, increasing audits to 8 per agent per month (from a prior standard of 5)
- Developed a quality assurance process which resulted in a 25% reduction in high impact errors during the first three months of implementation
0-5 years of experience
Verified dealership data files for integrity, accuracy and completeness before being delivered to clients using Quality Assurance guidelines.
- Used Athenticom processes and software to complete orders.
- Provided feedback to Client Services as needed so they knew what corrections and updates needed to be done so the order could be completed and then followed-up on these orders.
- Kept QA team up to date on any changes to processes or things we needed to know.
- Ensured quality improvements were continuously evaluated so that tools and techniques could be modified or upgraded to make sure all data being delivered was 100% accurate and complete.
6-10 years of experience
Guided various national title search providers in an effort to complete error-free title reports while exceeding service level agreements established with the bank’s fulfillment area. Direction resulted in annual 95% accuracy levels which met the bank’s expectations
- Identified and reported high frequency quality defects to national title suppliers during the course of the month in addition to regularly scheduled monthly conference calls to reduce risk exposure for the bank’s home equity product
- Composed and edited insured title search job aids located on the bank’s policy and procedure guide portal which provided audit flow details and reporting requirements. The job aids were critical for training purposes and meeting internal compliance standards
- Trained bank associate in the role of Quality Assurance Specialist which resulted in the continuation of a high quality title audit review. Over a three month training period, reduced defects from ten to zero
- Reduced overall risk exposure to the bank by reviewing individual real estate loan closing documents and escalated high risk issues to management
- Examined various vendor management performance monthly scorecards to determine the level of accuracy provided to the suppliers. Evaluated areas of the scorecard for performance issues in an effort to provide a better closing experience for the customer and reduce the bank’s risk in certain aspects of the closing process
0-5 years of experience
Monitored, measured, trained and improved the skills of over 350 customer service representatives by evaluating error patterns and recommending the types of training for each employee to supervisors.
- Successfully identified trends, best practices, achievement of goals and objectives and areas needing improvement by monitoring calls and providing analysis to agents, supervisors and management.
- Accurately determined where more training or one-on-one coaching may be needed by planning, scheduling and conducting monitoring and data analysis activities based on the Quality Metric set up by senior management.
- Increased customer satisfaction by preparing reports to communicate trends and findings and make recommendations as appropriate to senior management on monthly basis.
- Continuously improved monitoring standards by working collaboratively with the entire Q&A team.
- Improved quality assurance performance by effectively coaching agents.
0-5 years of experience
Refined, implemented and ensured the accuracy and completeness of the QA documentation system
- Assisted in internal investigation of sterility of reagents used in the manufacturing process
- Circulated new or revised documents for review or approval
- Archived and distributed all approved SOPs, BPRs and specifications
- Analyzed quality control data for trending
- Act as a liaison with vendors and auditors
- Wrote, reviewed and revised SOPs
10+ years of experience
Traveled throughout Idaho, Washington, and Oregon to inspect and certify produce
- Completed and maintained an accurate record keeping system and provide detailed information to contracting company
- Graded product to comply with USDA standards and grades per marketing orders
- Interacted with multiple agencies, owners and shippers to ensure quality outcomes were achieved
- Provided detailed training to other entities and individuals in order to consistency and timeliness
- Effective communication with a varied and invested level of participants
0-5 years of experience
Customer Service Representative
- Quickly accelerated to Quality Assurance Specialist within 3 months. Evaluated, coached and instructed all customer service representatives on the proper procedures in capturing a verbal vote from the shareholder.
- Ability to take initiative during training under minimal supervision.
- Supported, trained and provided important information and resources to the newly recruited employees on a number of campaigns.
- Reviewed and ensured that all customer service representatives were in compliance of quality assurance standards.
- Analyzed, evaluated and presented information concerning customer service representatives who may not be suitable for the environment.
0-5 years of experience
Reviewed & approved batch records & analytical data for drug substance & drug product.
- Established and maintained calibration and maintenance program for the analytical and quality control laboratories including establishing service contracts, writing SOPs, establishing and maintaining equipment files and electronic equipment status logs.
- Established and maintained employee training program including writing SOPs, establishing training files, tracking training status, and arranging training sessions.
- Assisted in maintenance of electronic deviation status log.
- Assisted in establishing and indexing new QA document archive room.
- Performed all aspects of document control function from Aug 99 to Aug 00.
- Wrote and revised SOPs and test methods.
0-5 years of experience
Oversaw all project production and efficiency standards in compliance with company policy.
- Performed random audits throughout project duration to ensure application of standards by members of staff.
- Recommended ideals to improve production standards across the board, increasing volume while preserving efficiency.
- Assisted project manager with determining project manpower, training, and scheduling needs as necessary.
0-5 years of experience
Managed the commands Quality Assurance Program in support of overall command mission
- Oversaw the accuracy in the assembly, disassembly, storage and inventory of over 40,000 underwater mines and associated components.
- Audited and inspected the facility’s entire inventory on a regular basis and provided reports to management.
- Lead to the increase of inventory accuracy from 82% to 97% in a 9-month time span.
- Implemented and maintained quality assurance training plan
- Operations Department Head: (15 Personnel)
- Supervised and coordinated all accountability, transit, stowage, maintenance, inventory, safety and issuing of pre- positioned war reserve stock of underwater service and exercise/training mines to meet worldwide rapid deployment of mining mission operations.
- Managed the perpetual database for the inventory/ accountability of all explosive mine material in the Pacific Fleet to include the entire west coast of the United States, Hawaii, Guam and all of Japan.
- Maintained the official database of over 250 mine-like contacts identified by U.S. and Coalition Forces during Operation Enduring Freedom/Iraqi Conflict
0-5 years of experience
Monitored the automated problem management system and reviewed records for accuracy and completion.
- Ensured accuracy of documentation for updating electronic medical records.
- Trained and evaluated medical transcriptionists to reduce errors and ensure efficiency.
- Performed audits to monitor quality and stability of products.
- Facilitated QA inspection functions as assigned by the QA manager.
6-10 years of experience
Provided quality Assurance support and contract management for Defense Contracts.
- Performed Source inspector for sustainment of mature life cycle programs.
- Provided First Article Inspection for initial builds and programs for new material and programs. Maintained Pre-award and Post award surveys for completion of project milestones and the attainment of client goals.
- Investigated Product Quality Deficiency Reports on behalf of the government.
- Accepted contracted material and equipment on behalf of the Government.
6-10 years of experience
Recognized for dependability, professionalism and the ability to “get it right” the first time.
- Oversaw all Subcontractor’s installation equipment in accordance to policy and guidelines.
- Ensured approved parts and electronic components are used on Subcontractor’s equipment.
- Delivered exceptional skills in de-escalating and diffusing intense situations in the field.
- Inspected and verified installations for proper equipment and adherence to policy.
6-10 years of experience
Recognized for dependability, professionalism and the ability to “get it right” the first time.
- Oversaw all Subcontractor’s installation equipment in accordance to policy and guidelines.
- Ensured approved parts and electronic components are used on Subcontractor’s equipment.
- Delivered exceptional skills in de-escalating and diffusing intense situations in the field.
- Inspected and verified installations for proper equipment and adherence to policy.
0-5 years of experience
Reviewed procedures for all significant risk activities: plan or source changes, fund additions, fund mappings and updates.
- Validated user’s wok, tracked defects, ad provided feedback to user and manager about the status of retirement plans.
- Performed defect analysis, identified process improvements, and carried out product reviews
- Supported the development and implementation of improved quality reporting measures.
- Reviewed quality related customer complaint investigations and trending activities.
- Collaborated with various teams to ensure retirement plans, fund additions, and fund mapping were updated within the stated guidelines.
0-5 years of experience
Promoted to Project Coordinator in one year of being with [company name], then promoted to Quality Assurance Specialist II after an additional year
- Qualifies medical professionals that want to establish a direct vaccine purchasing account with MERCK & Co
- Experience in Customer Data and researching applications such as MedPro ID, MERCK’S Application Administration software, and SAP (Systems Applications Processing)
- Followed the 24- 48 hour Service Level Agreement, pushing out 94% eligible candidates for direct purchase within 24 hours
- Received “Yellow Belt” training and certification for SIX SIGMA
6-10 years of experience
Performed online quality-assurance testing for system-development life cycle on Unisys V560 mainframe.
- Developed and maintained test-script library to streamline evaluation of software performance.
- Coordinated release and implementation activities among development, production control, management and user groups.
- Trained new computer operators and coordinated shift schedules.
0-5 years of experience
Strategically troubleshot and maintained the Loan Quality Assurance Software program. Provided in house customer service in the usage of computer system
- Trained employees in the use of new loan management software; Supervised between 2 and 4 persons during hardware transition period; Designed and assisted in the creation of documents using the Crystal Reports Software
- Assisted in outsourced and in-house auditing of loan documents
- Printed daily auditing report for the purpose of editing loan documents
- Prepared and organized reports using Crystal reports software as well as Microsoft office suite software
- Analyzed and researched information and developed plans for projects
- Assisted in the daily office equipment and computer troubleshooting and repair for my department
- Assisted with the time to time need for installing of equipment and performed several maintenance duties
- Quoted pay-off amounts to customers; posted loan payments; entered data for HMDA using Centrex software; processed paid out loans and returned Deeds to customers
0-5 years of experience
Provided coaching, guidance and direction to manufacturing staff in regards to compliance and execution of their processes, procedures and use of quality systems.
- Ensured compliance with internal SOPs by participating in plant floor audits of procedures and processing of themanufacture of biological products.
- Reviewed and approved Equipment Cleaning Logs, Work Orders, Manufacturing Batch Records and SOPs.
- First Amgen-Colorado quality group employee to oversee overnight manufacturing operations: ensured batch record/equipment log entries reviewed/corrected in real time; saved quality day-staff review-time and prevented possible non-conformances.
6-10 years of experience
- Coordinated data compilation and comprehensive review and disposition of sterile injectable vaccine product.
- Lead process improvement project to increase data availability of department information for use by other business groups.
- Collected and assessed batch data collected from various electronic and paper-based sources and evaluate regulation conformance.
- Enhanced records management system for Board of Health Protocol documentation; generated electronic versions of paper documents, eliminating non value-added/ duplicate work.
- Managed chain of custody from receipt through transfer to records retention for batch related documentation.
- Daily use and authoring in multiple electronic systems (TrackWise, SAP, SAPCAPA, LIMS, GXPharma)
0-5 years of experience
Reviewed complaint and provider self-reported incident intakes to ensure compliance with federal and state requirements, laws, regulation, policy, and procedures for prioritization of intakes for long-term care facilities, including nursing homes, assisted living, and adult day care.
- Conducted quality monitoring activities and edited intakes prepared by intake specialists prior to forwarding to the region office for investigation to ensure QC and accountability standards were maintained.
- Referred intakes to other agencies when appropriate.
- Facilitated collaborative relationships by consulting and guiding key stakeholders, delivering subject matter expertise to intake staff, program staff, providers, consumers, and internal and external stakeholders.
- Completed professional reviews in accordance with established policies and timeframes and assisted with intakes of complaints, incidents, and requests of information to ensure timely triage and management of intakes.
6-10 years of experience
Provided accurate, specific and timely quality assurance performance.
- Cross-trained and supported other quality assurance monitors
- Met or exceeded service and quality standards every review period.
- Initiated operations improvements to improve overall call center productivity.
- Prepared reports and communication for senior management and clients.
- Monitor customer calls effectively and efficiently in a complex, fast-paced and challenging call center environment.
0-5 years of experience
Promoted after 5 months of employment.
- Ensures that Customer Support Agents are complying with all HIPPA standards in accordance with our contract.
- Participates in the design of quality monitoring forms and quality standards.
- Oversaw the design and implementation of spreadsheets created to provide an overview of center-wide trends and coaching opportunities.
- Assists with several record keeping systems as well as provides feedback to improve the proficiency of these systems.
0-5 years of experience
- Enrolled youth participants into PYN’s client tracking system (PYNDEX)
- Quality reviewed youth file information to ensure eligibility and enrollment completeness for the Summer WorkReady program
- Ensured that the following data was validated with appropriate documentation: Name, Date of Birth, SSN, Address, City, State, and Zip Code
- Managed and Maintained physical participant documentation in PYN’s filing room
- Assisted other PYN staff members as needed
0-5 years of experience
- Reviewed quality assurance data and supported new business compliance initiatives
- Led and assisted in investigating client disputes and complaints
- Analyzed customer quality assurance programs and provided prompt feedback via tailored reporting
- Recommended actions to improve overall quality control processes and work flow
- Executed general program education and calibration as part of field support and evaluations
0-5 years of experience
- Conducted internal audits for compliance to ISO 13485 and company quality system
- Participated in ERP related activities including trouble shooting, training and implementation
- Studied and analyzed compiled data and reported overall trending of the quality systems including key performance metrics
- Supported investigation activities for OOS failures, CAPA events / nonconformance and customer complaints
- Lead special company and corporate initiatives and projects such as performing final quality inspection on specific implantable textile products prior to shipment and training
- Prepared and revised Work Instructions (WI), Standard Operating Procedures (SOP), Document Change Requests (DCR) and Supplier Corrective Action Requests (SCAR)
0-5 years of experience
Developed Quality Assurance processes and methods to test software applications, new releases and new client deployments. This involved developing protocol to ensure new functionality is correctly implemented, known bugs are fixed and regression testing is performed.
- Responsible for all testing of the Helix Pharmacy System which included electronic claims processing and Vendor Ordering System software. Billing and revenue reporting software, EMR interfaces including Prescribers Connect, Matrix Care, AOD, Surescripts, Sigmacare, Net Rx, Optimus and Scriptalk.
- Responsible for final signoff on quarterly software releases.
- Provide post implementation support and training for product customizations.
- Effectively worked with Director of Product Assurance, Director of Programming and Programming Department to meet deliverable deadlines for various projects
- Provided 90 day software support for all new clients to ensure customer satisfaction post software installations.
- Involved in the planning, development and deployment of new software projects.
0-5 years of experience
Operated as Quality Subject Matter Expert (SME) to ensure compliance for manufacturing and operations processes through observation, audits, inspection, sampling and process improvement.
- Increased QA availability by 1.5 hours by streamline quality audit program which resulted in concise reporting, thorough follow-up and ease of management.
- Developed a quality audit tracking system to manage trends, identify process gaps, and to encourage the sharing of best practices.
- Imposed real time quality decisions making for deviation determination which included to stop work, product impact assessment, segregation, quarantine, investigation initiation, discard, employee interview, triage, investigation and product reconciliation.
- Reviewed/ Revised/ Created SOP’s based upon systematic requirements, identified gaps and regulatory alignment.
- Communicated pertinent quality information and business needs via crossover meetings and email distribution.
- Provided oversight and sign-off for protocol and qualification initiatives.
- Promoted quality culture through leadership, empowerment, and coaching.
- Utilized TrackWise, MES, HMI/PLC.
0-5 years of experience
- Provided coaching, guidance and direction to manufacturing staff in regards to compliance and execution of their processes, procedures and use of quality systems.
- Ensured compliance with internal SOPs by participating in plant floor audits of procedures and processing of the manufacture of biological products.
- Reviewed and approved Equipment Cleaning Logs, Work Orders, Manufacturing Batch Records and SOPs.
- First Amgen-Colorado quality group employee to oversee overnight manufacturing operations: ensured batch record/equipment log entries reviewed/corrected in real time; saved quality day-staff review-time and prevented possible non-conformances.
0-5 years of experience
Performed Maintenance, Engineering, Operations surveillances and audits to assess compliance with applicable NRC, NQA-1, DOE regulations and requirements.
- Assessed effectiveness of corrective actions.
- Wrote surveillance and audit reports.
- Reviewed procedures, test programs, maintenance work packages for adequacy.
- Wrote Assessment and Tracking Reports to resolve deficiencies.
- Assured SAR and USEC Quality Assurance Plan requirements were met.
0-5 years of experience
Served as Lead Quality Assurance Specialist for the Canadian Flying Training and Support (CFTS) project
- Collaborated with instructional designers, Subject Matter Experts (SMEs), and programmers to develop content for computer-based training and computer-assisted instruction, progress and evaluation reports, and collateral materials
- Evaluated test questions and quality of interactive graphics and simulations
- Edited a PowerPoint training presentation for Smiths Detection, a manufacturer of equipment used at airports to detect particulates of drugs, explosives, and other harmful substances
- Edited computer-based training for U.S. Navy medical services
0-5 years of experience
Identified gaps and enhancements for existing processes.
- Support testing of cross functional changes.
- Developed, evaluated and expanded on solutions for requirements.
- Negotiated process solutions cross functionally with all appropriate groups.
- Developed all procedures and end-user training.
0-5 years of experience
Evaluate all agents (9 departments) to create workflow efficiency and improved customer service.
- Identify unsuccessful implementation of company policies and provide resolution, in collaboration with Human
- Train current and new employees to exceed customer expectation, sustain client satisfaction
- Analyze standard operating procedures and assist Quality Assurance Manager with updating the evaluation
- Review/ update accounts and contracts for accuracy
- Resolve account issues obtaining 35 or more new contracts per month.
- Manage accounts and daily queues via email and inbound/outbound calls
0-5 years of experience
Support the manufacturing quality assurance team including: Quality Managers, Engineers and Production Supervisors
- Provide support and guidance on Quality System Requirements (QSR) and ISO/FDA quality requirements
- Perform pilot run and process/operation audits. If needed, provide solutions to the audit findings
- Approve and close Quality Notifications (QN’s)
- Handle Delivery Holds for national and international shipments
- Implemented a training procedure that resulted in reduced cost of QN’s
- Developed auditing checklist to standardize the auditing procedure across multiple facilities
6-10 years of experience
Ensure compliance with the Oregon Administrative Rules and company policies/procedures in assigned programs (adult and youth programs in various service lines).
- Extensive monitoring of documentation completed by staff, monitoring accuracy and implementation of the Oregon ISP processes specific to each service line. Coordination of supervision and follow up required to correct any deficiencies identified during my QA reviews
- Write and implement medical support plans and medical protocols/procedures for all individuals in assigned programs, others as assigned.
- Teach medication administration levels 1 and 2 as well as new hire orientation to our directors, managers, assistant managers and direct support staff members.
- Create and implement company policies and procedures with team members as new procedures within the company were needed.
- Daily computer use of internet, company network and databases, e-mail and Microsoft programs.
0-5 years of experience
Performed nondestructive testing (liquid penetrant) on 100 feet of pipe welds per day on submarines for the United States Navy
- Obtained a Secret security clearance from the Department of Defense to perform nondestructive testing on nuclear submarines
- Completed 40 hours of classroom training in liquid penetrant
- Completed 160 hours of on-the-job training under the supervision of the United States Navy
- Increased operational productivity of the Quality Assurance department by 200% within one month through process improvement suggestions and by scheduling projects simultaneously
- Performed Nondestructive testing (magnetic particle) on 150-175 feet of structural welds per day on nuclear and non-nuclear submarines for the United States Navy
- Reading blueprints and schematics of electrical, structural, Ferromagnetic and Non-Ferromagnetic components to determine inspection site and the location of welds
- Repair and retest surface detects on piping and structural welds
- Performed daily tasks under the supervision of NAVSEA
0-5 years of experience
Promoted from Customer Service Advocate to Quality Assurance Specialist within the Customer Experience Management department.
- Monitors a statistically valid sample size of recorded and live calls for the client and objectively correspond information gathered to supervisors and customer service agents
- Effectively communicate corrective action reporting for immediate feedback
- Routinely provides guidance to and assists in the training of less experienced staff
- Performs as Customer Engagement Representative based on company need
- Facilitate advocate coaching and listening sessions to improve performance and customer experience.
6-10 years of experience
- Quality assurance editor for publisher of standardized achievement tests, instructional manuals and various other educational materials
- Duties included copy editing and fact checking of printed and online test items for correct grammar and accuracy
- Provided editorial reviews of printed items transferred to online platforms. Ensured items contained no grammatical errors and were formatted correctly
- Developed and maintained style specifications for items and ancillaries of various projects
- Supervised and offered guidance to team of outsourced vendor editors providing editorial reviews of ancillary materials, such as examiner’s manuals. Performed read-behinds of ancillaries reviewed by vendor editors to ensure materials contained no grammatical errors and conformed to the project’s style specifications
0-5 years of experience
The Quality Assurance Specialist, first and foremost, acts as a client advocate, ensuring that clients are provided quality services in a manner consistent with company’s mission- CARE FIRST.
- Ensuring client satisfaction with services rendered by caregivers
- Completing new client intake paperwork
- Conducting monthly telephonic and home visits with a caseload of approximately 95 clients covering 13 counties
- Filing critical and internal incident reports
- Conduct training for new caregiver staff to include personal skills demonstrations
- Maintain confidentiality of client information and business trade practices
0-5 years of experience
Perform audits on completed Medicaid Renewal Cases to ensure all policies and procedures were followed during processing
- Prepare report monthly detailing the outcome of past month’s audits
- Perform audits on Document Management department to ensure that all documentation received is processed properly and that all confidential information is being handled in accordance with HIPPA guidelines
- Analyze data from audits to identify emerging error trends
- Create strategies and activities to address and correct identified error trends
- Provide one-on-one coaching sessions to underperforming call center associates
6-10 years of experience
Monitored the accuracy of account maintenance/adjustments and protected price templates as submitted by Customer Care Specialist.
- Created protected pricing plans per customer agreement and company policy.
- Ran VCQ reports daily.
- Meticulously reviewed and corrected credit and debit adjustments before sending to the Accounting Department.
- Terminated and placed Early Termination Fees (ETF’s) on accounts.
- Applied prompt pay credits on customer accounts.
- Created and sent Pricing Confirmation Letters to customers.
- Investigated and resolved account issues for customers, customer service and upper management.
- Assist with day to day efficient operations of the office: Filing, massive mailings, data entry, mail merging, bookkeeping, word processing and creation of spreadsheets.
0-5 years of experience
- Generated weekly performance reports and created daily tracking charts to monitor operations team progress
- Managed relevancy of audit standards by updating them each quarter in production platform to fit client requirements
- Supported special projects team to fulfill unique client requests that could not be addressed with current product and service offerings
0-5 years of experience
- Performed Quality Assurance for Manual Testing as a sub-contractor for Northrop Grumman.
- Provide Quality Assurance testing for over 12 sub system requirements for Air Operations Command Weapons Systems (AOC/WS).
- Maintained project completion by follows a strict process flow, through coordination with government approved testers.
- Liaison for Northrop Grumman and appropriate Government officials on testing procedures and overall quality assurance.
0-5 years of experience
Monitor customer service calls ensuring correct and complete information is being provided
- Research and reference Accidental Death Policies and agreements
- Calibrate with various teams for scripting, cross sell, and retention implementation efforts
- Conduct weekly coaching sessions with tenured call center staff providing quality scores, developing customer service and sales skills
- Conduct daily feedback coaching sessions with new hires
- Develop new hire quality assurance training processes
0-5 years of experience
Managed team of compounding pharmacy technicians
- Trained incoming technicians in sterile technique
- Managed scheduling of product manufacturing
- Liaised with various departments, including accounts payable and shipping to ensure seamless manufacturing process
- Ensured compliance with cGMP regulations
- High degree of familiarity with USP 797 standards
- High degree of familiarity with Cleanroom and Sterile compounds
0-5 years of experience
Coordinate Production Requirements.
- Respond to Customer concerns, including root cause investigation.
- Develop and update quality documentation (ISIR) for customers.
- Coordinate and manage APQP System in compliance within TS16949 standards.
- Assist in the performing Supplier and Internal Audits.
- Assisted with surveillance audits for ISO9001, TS16949 and CCC.
- Assist with development of production processes, in addition to training and management of Production Associates.
0-5 years of experience
Provided monthly oversight of agency EHR (EVOLV) to ensure delivery of quality service
- Ensured client record compliance with regulatory requirements (DBHDS/Medicaid/CQL)
- Scheduled, documented and managed quarterly/annual QA + I meetings
- Audited community respite home to ensure environmental standards according to OSHA
- Responsible for quarterly performance reports related to EHR non-compliances
- Implemented and conducted trainings related to improvement of QA goals/outcomes
- Trained direct care staff to assist with program development
0-5 years of experience
- Review claims to ensure superior delivery of claims services/products.
- Training to be sure Team Members are in compliance with regulatory and company standards.
- Monitor phone calls for quality assurance. Making sure claims process is explained to the caller, recognize any underlying issues, and that all phone objectives are met.
- Met with 10+ Claims Representatives weekly to give coaching and feedback. Reviewed the files and discussed with representatives. Listened to calls and calibrated what was done well and what could have been done differently.
- Assist Team Managers when needed, and monitored phones.
Quality Assurance Specialist Duties and Responsibilities
Quality assurance specialists work in a variety of organizations. Specific duties and responsibilities may vary, but there are several core tasks associated with the job, including:
Identify and Resolve Production Issues In some industries, quality assurance specialists perform quality tests during production to identify and correct any work-in-progress issues. They create and implement monitoring processes and ensure that production employees are adhering to standards and safety guidelines.
Conduct Product Testing and Audits Quality assurance specialists also perform routine inspections of finished products to check for defects and other problems before these products are shipped for distribution. They identify problems, separate defective products from non-defective products, create audit reports, and record corrective procedures to resolve product non-compliance.
Document Product Tests and Corrections Once a product has been tested and found defective, quality assurance specialists meet with superiors to address issues and discuss resolutions. They maintain records of product tests and defects and summarize corrective actions taken.
Evaluate Production Operations Quality assurance specialists observe production operations and make suggestions for improvements to minimize errors and defects in products.
Create Training Materials They also create operation manuals and training materials that outline operation processes and any updates to procedures or practices within the manufacturing or production process.
Quality Assurance Specialist Skills and Qualifications
Detail-oriented individuals with analytical minds and strong communication skills make great quality assurance specialists. Employers tend to seek candidates for this position who demonstrate the following:
- Technical Skills – Understanding quality assurance as well as production technologies and systems is crucial in this role
- Computer Skills – Knowledge of Microsoft Office Suite programs, such as Word and PowerPoint, is necessary for QA specialists to produce documents, reports, and presentations
- Commercial Awareness – These specialists must be experts in industry standards impacting inspection and quality control techniques and procedures
- Communication Skills – Strong oral and written communication skills for making presentations, explaining quality improvement plans, and producing testing and quality assurance reports is necessary for this profession
- Attention to Detail – The ability to detect issues from among many products and review every aspect of production operation calls for a keen eye for details
- Team-Oriented – QA specialists work closely with quality control managers, production workers, quality engineers, inspectors, and other personnel
- Analytical Skills – Analyzing production processes and applying this skill to the inspection of products is central to this role
- Time Management – Most companies strive for quick turnaround from the detection of a product defect to implementation of viable solutions, so these specialists produce results in a timely manner
Quality Assurance Specialist Education and Training
Most employers require only a high school diploma for those seeking to become a quality assurance specialist, though education requirements can vary depending on the industry. For instance, quality assurance specialists working for technological or software development companies may be required to hold at least a two-year degree in computer science or computer engineering. A bachelor’s degree is often required to advance in this field. In many cases, these professionals will receive on-the-job training to learn inspection procedures and the use of any automated equipment.
Quality Assurance Specialist Salary and Outlook
The Bureau of Labor Statistics (BLS) reports that the median annual salary for quality assurance specialists is just over $37,000. Those specialists earning in the lowest 10th percentile make about $22,500, while top earners receive a median annual wage of over $64,000. QA specialists working in the technical field tend to make the highest median annual wage at $40,000, followed by those in manufacturing at nearly $38,000 per year. QA specialists typically receive medical benefits, vacation leave, retirement plans, paid holidays, and in some cases, bonuses. The BLS predicts an 11 percent decline for this profession over the next decade or so, as some companies incorporate automated systems to conduct quality control inspections and tests. Growth, however, could be seen in industries that cannot rely on automated quality control inspections.
Helpful Resources
Want to learn more about what it takes to become and find success as a quality assurance specialist? If so, check out the following texts and organizations to help you explore this occupation:
Society of Quality Assurance (SQA) – Quality assurance specialists and other quality control professionals can benefit from training webinars, live training sessions, quality assurance conferences, access to publications, and reviews of regulatory resources as members of the SQA.
Quality Assurance: Applying Methodologies for Launching New Products, Services, and Customer Satisfaction (Practical Quality of the Future) – This book outlines the best approaches and practices as defined in the continual improvement (CI) process, by which an organization can help ensure that they are producing the highest quality and most satisfying products for their employees.
Quality Assurance: Philosophies, Methods, and Technologies – Any QA specialist who wants to review effective inspection techniques, explore basic quality assurance tools, and understand the statistics associated with quality assurance turn to this introductory book.
American Society for Quality (ASQ) – From personal certification to recent quality assurance news, ASQ brings together QA professionals from more than 130 countries. Networking, world conferences, a learning institute, and professional publications are just a few of resources quality assurance specialists enjoy as members of ASQ.