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10+ years of experience
- Provided workflow analysis and process improvement for the Physician Practice Services Department of a technology company engaged in promoting business management solutions and streaming healthcare operations.
- Ensured consistent adherence to quality and compliance procedures, meeting internal and external requirements.
- Developed and executed corrective action plans as needed, mentoring employees to properly execute such plans.
- Led all departments to meet 99% productivity standards consistent with the Department’s quality objectives, completing projects on time, within budgets, and conforming to system platform specifications.
- Collaborated with department managers in resolving Client account inquiries.
0-5 years of experience
- Evaluated risks and interacted/collaborated with management regarding implementing changes in the work environment conducive to growing the business
- Responsible for meticulously auditing randomly selected claims daily for each claims professional
- Prepared timely audit reports with recommendations that add value to each employee’s role
- Conducted meetings with claims professionals to discuss audits and potential changes to prevent future errors
- Gathered audit data from reports monthly (15 audits per month/30 representatives) to present to management and maintain organization within the department
0-5 years of experience
Process/Systems Quality Auditor II
- Responsible for the design and execution of Quality Management Systems as defined by the FDA and expectations of PPD Clients
- Conduct internal audits of PPD process and systems, in collaboration with the functional department defines problems and problem solution strategies, establishes quality and performance matrices and analyzes trends and presents results to peers and senior management
- Serve as the corporate subject-matter-expert for the development and delivery of training initiatives regarding Quality Management
- Produced and maintained audit plans for allocated projects, and identifies audit candidates. Conducted GCP audits and study document reviews
- Provided consulting to internal PPD staff on issues of GCP compliance
- Prepared and presented information at Client sponsored meetings, internal team meetings, and in-service programs to study team personnel on GCP issues with minimum guidance
- Coordinated preparations, hosting activities, reporting and follow-up for client audits of project specific files, database and PPD facilities and systems
- Provided training and mentoring to new CQA staff
- Assisted with designated management tasks when requested by CQA management
0-5 years of experience
- Reviewed claims from claims reviewer to insure accuracy
- Communicated with managers and reviewers to correct inaccuracies within individual claims
- Sent feedback to reviewers on how to correct their review practices
- Consistently ranked as one of the top auditors in quality and quantity measurements
0-5 years of experience
- Performed audits of data, master files, database and all research documentation in regards to accuracy of the data, and compliance with protocols, SOPs, GCPs, IRB, and FDA/ICH guidelines (4 Phase II vaccine protocols)
- Recommended corrective actions for resolving clinical, compliance issues and followed-up accomplishments
- Revised and updated Standard Operative Procedures.
0-5 years of experience
- Planned, conducted and monitored.
- Tested, inspected materials and products to ensure finished materials.
- Documented internal audits and other quality assurance activities.
0-5 years of experience
- Designed Internal Quality Program and implemented for all 3,000+ employees nationwide
- Performs operational audits of 120+ locations nationwide, verifying that all processes and procedures are being properly completed
- Provides training on company processes and procedures to all employees
- Completes process evaluations based on opportunities seen throughout the company
- Manages customer satisfaction metrics, both internal and external to the company
- Evaluates all insurance for vendors on the company’s Approved Vendors List
- Working knowledge of ISO 9001:2008 and 9001:2015 Standards
0-5 years of experience
- Conducted audits of GLP and GMP projects.
- Reported audit findings to management.
- Maintained the Quality Assurance logbooks and GLP Master Schedule.
- Reviewed Sample Receipt performance.
- Reviewed Metrology Documents.
- Performed all required duties in compliance with the company SOPs.
6-10 years of experience
Effectively communicate and maintain positive relationships with departments to resolve noncompliance issues and analyze practices for maximum efficiency
- Demonstrate ability to effectively complete tasks and meet deadlines; prioritize requests and manage multiple projects
- Thoroughly audit procedures to ensure quality deliverables to clients
- Provide detailed review of scientific reports to ensure contents accurately reflect the study data and methods
- Generate inspection reports and submit findings to management and study director
0-5 years of experience
- Ensures/verifies compliance for multiple insurance carriers internally by viewing supporting documents, multiple internal systems and operating installation practices.
- Communicates installation errors by identifying, preparing & recording vital information using multiple Excel spreadsheets.
- Prepares multiple reports monthly/quarterly by analyzing operating data & inventory by using Excel and VBA/Macro coding to ensure accuracy to meet departmental goals.
- Organize/prepare weekly meetings to develop/implement new ideas, approaches & technology improvements to enhance production, communication & client satisfaction/accuracy.
- Effectively communicate carrier regulation/guidelines upon modification to all colleagues by creating Standard Operating Procedures.
0-5 years of experience
- Managed and lead teams in sales and customers service oriented organizations for 20 plus years with direct reports of 15 plus individuals.
- A pragmatic manager with excellent skills in planning, scheduling, defining, measuring, analyzing, improving and controlling quality attributes to meet excellent end results.
- Consistent track record of providing superb customer service in meeting customer needs.
- Knowledge and expertise in sells, coaching and motivating individuals.
- Self-motivated with strong team leadership traits, multi-task capabilities, excellent communication and organizational skills.
0-5 years of experience
- I am required to have good communication skills as every day before shift, I take a pass down from the previous shift on how the product ran, and on any issues that may have gone on. I also have to communicate well on the radio to other plant operators when issues arise with the product.
- Every twenty minutes I take samples of the product produced. During each sample, I run the product through a series of tests to make sure that it accurately complies with the customer’s specifications.
- I take instruction from my direct supervisor, and was trained and watched for 90 days on how to properly run all of the tests needed to
- Every month I complete safety observations, work trainings, and attend random meetings as they are scheduled.
- I am consistently required to do multiple tasks at a high speed, while recording data on several computer applications, and using company provided machines.
- I must pay great attention to detail while ensuring no errors- especially when it comes to checking the codes on every bag of every product.
- Every day I work together with multiple other operators to ensure that the product turns out correctly throughout every stage of the production process, and to ensure that it follows the customer’s specifications 100%.
0-5 years of experience
Possess thorough in-depth knowledge and clear understanding of Good Clinical Practices (GCP), International Conference on Harmonization (ICH) guidelines, Federal Drug Administration (FDA) guidelines, Current Good Manufacturing Practices (cGMP) and HIPPA rules and regulations.
- Conduct internal compliance audits on multiple Phase I clinical trial studies for their compliance with state/ federal regulations, investigational plan (IRB approved protocol) and company standards.
- Oversee the reported trial data is accurate, complete and verifiable from source documents.
- Perform monthly in-process audits observing technical and professional staff on procedures making sure they are adhering to protocol specifications and internal standard operating procedures (SOPs).
- Perform quarterly employee training record audits on current staff to assure appropriate education and training of staff’s particular roles in the trial are met.
- Assure implementation of any resulting corrective action plan (CAPA).
- Utilize audit outcomes to identify quality related trends and areas of risk appropriately escalating any issues to relevant management personnel.
- Ensure the documentation of storage, handling, dispensing and return of investigational product (IP) are completed per protocol and company SOPs.
- Audit regulatory and essential documents for completion and accuracy
- Ensure effective closure of audits by working with ‘auditees’ to ensure comprehension, development and execution of corrective/preventative actions with regard to any non-conformities cited during audits.
6-10 years of experience
- Mentored and trained customer service representatives on quality standards, to include documentation in various systems.
- Reviewed quality standards, performance goals, and assisted with the development of training programs
- Subject matter expert for monitoring and screening calls
- Provided feedback to associates
- Conduct root cause analysis studies
- Respond to internal and external customer inquires
- Give understandable explanations for benefit and billing inquiries
- Build trust with members and brokers in order to provide guidance
- Meet and exceed quality standards consistently
- Provide support for new hires and tenured peers that are not meeting QA standards
10+ years of experience
- Supervised auditing of establishments and determined scope of investigation required. Prepared detailed reports on audit findings, asset utilization and audit results. Recommended changes in operations for increased quality and efficiency. Completed production reports to notify management of production levels.
- Supervise assemblers and trained employees on job procedures. Set up and verify the functionality of safety equipment.
- Collected and analyzed data to detect deficient controls, duplicate efforts, fraud, or non-compliance with legal regulations and management policies.
- Inspect account books and accounting systems for efficiency, effectiveness, and use of accepted accounting procedures to record transactions. Examine records and interviewed workers to ensure recording of transactions and compliance with legal regulations.
- Examined and evaluated financial and information systems, recommended controls to ensure system reliability and data integrity.
- Performed quality checks on products and parts. Packaged finished products and prepared them for shipment. Monitored and adjusted production processes or equipment for quality and productivity. Troubleshoot problems with equipment, devices, or products. Tested products or subassemblies for functionality or quality. Inspected finished products for quality and adherence to customer specifications.
- Confer with vendor by telephone or in person to provide information about products or services, and obtain details of complaints. Verified solutions to ensure that appropriate changes were made to resolve vendor’s problems. Maintained records of vendor interactions, complaints or comments, as well as actions taken. Referred unresolved customer grievances to designated departments for further investigation.
- Contacted customers to respond to inquiries or to notify them of claim investigation results or any planned adjustments
6-10 years of experience
Manage internal quality audit program and maintenance of files and documents.
- Monitoring the compliance of processes and associated records to company standard operating procedures.
- Manage closure of assigned deviations, non-conformance, corrective and preventive actions
- Assist in collecting status of in- process finish goods and update in AS-400.
- Initiate investigations for non-conformance raw material, bulk, and finish goods.
- Support deviations and non-conformance documentation process utilizing PQM.
- Investigate external and internal complaints using data in PQM
- Coach and mentor QA and Packaging departments on GMP’S and SOP’s.
0-5 years of experience
- Tasked with Auditing 75+ calls per week.
- Give feedback to agents from audits, make sure coaching is implemented.
- Track progress of individual agents and create glide path based on agent specific metrics.
- Lead Rep-assisted with floor support at its busiest.
- Peer Guidance, helped struggling agents, assisted with growth and development.
- Trained and Ran QA Calibrations for our Center and Enterprise wide.
- Researched Escalated Customer issues, problem solved and resolved issues, followed by customer call back.
- High Level of PC knowledge, Proficient in Excel and Excel formula creation.
- Highly Motivated, great time management skills, positive, and friendly attitude.
0-5 years of experience
- Handled all product complaints in a timely manner
- Managed recalls
- Kept company in compliance with DEA and FDA regulations
- Audited company procedures
- Trained new hires
0-5 years of experience
- Conduct image checks on all 3rd party computer pallets that are recieved in.
- Manage all hospital lanes along the packing line and fix issues that arrise at these stations.
- Conduct process audits on other departments.
- Verify all LTL pallets that are built and take pictures of all pallets and paperwork before shipments.
- Conduct open box checks to verify client orders and proper shipping addresses.
- Sent end of day report regarding team overall quality numbers and a recap of the shift.
0-5 years of experience
- Review Laboratory notebooks and data tables for compliance with Good Laboratory Practices
- Work with other Quality Assurance and laboratory staff to ensure reporting accuracy
- Advise and train staff on GLP policies and internal Standard Operating Procedures
- Develop and maintain strong communication and working relationships with internal teams as well as external clients
- GLP Archivist
0-5 years of experience
- Ensure company is compliant with applicable regulations and SOP’s by auditing protocols, data, reports, and conducting experimental phase audits for in-vivo, and in-vitro toxicology.
- Interpret EPA, FDA, and GLP regulations and ensuring adherence and compliance within the laboratory.
- Generating reports for all quality assurance audits, inspections and QA statements.
- Communicate audit findings to Study Director, management and follow up on corrective actives.
- Maintains the QA Master Schedule.
- Supporting facility audits from external government agencies.
0-5 years of experience
- Inspect the Mercedes Benz R Class in Voice of Customer Audit GFP and pre final inspections with ascore of 95% with an Indepent Quality Team from Mercedes Benz Germany
- Conduct an annual audit of all CCC certificate parts for the China market
- Knowledge of GFP, EAK and the VoCA audit, so that each stage of the audit process could have a boost when overwhelmed with product.
0-5 years of experience
- Completes weekly audits to ensure documents are compliant with state guidelines
- Organizes correspondence with personnel to review audits found in noncompliance errors/improvements/guidelines to ensure proper documentation is completed
- Prepares monthly activity and claim reports to resolve errors in documentation to ensure proper financial compensation
- Organizes and provides new-hire training for new-hire behavioral health staff
- Completes intakes, reauthorizations, and individual counseling in clinic for LCSW requirements
0-5 years of experience
- Responsible for ensuring product meets the established standards of quality including performance, reliability and durability
- Remove all products and materials that fail to meet specifications
- Prepare reports to communicate outcomes of quality activities
- Fulfilled and shipped E-Commerce orders
0-5 years of experience
- Operating complex testing equipment in verifying that final product meet specification.
- Performing dimensional inspections.
- Initiating and making copies of final inspection paperwork.
- Tracking and maintaining NCMR’s and material testing products.
- Performing specification training for production employees.
- Quarantining product when discrepancies are noted.
0-5 years of experience
- Lead compliance testing of internal controls and financial reporting under User Acceptance Test (UAT), Sarbanes-Oxley (SOX), SOC1 and SOC2 reviews.
- Serve as Team Lead for the Direct division (REO, Short Sale, Auction, Vendor Management, and Foreclosure department)
- Develop and maintain an in-depth understanding of business areas, its products, and supporting functions by partnering with the line of business management team, data analytics resources, and stakeholders.
- Work with line of business managers to coordinate responses and develop action plans responding to deficiencies and/or recommendations noted from internal, external audits, regulatory examinations, as well as self identified by management including SOX and SOC audits.
- Communicate audit findings to various levels of management and identify opportunities to improvement in the design and effectiveness of key controls.
- Manage overall growth, extension, quality, program implementation and supervision of the REO, Auction, Field Services, Closing, and Foreclosure Trustee department. Develop test programs to ensure compliance with all applicable federal and state regulations, along with investor requirements.
- Create risk metrics and assist in writing procedures for each business unit.
- Oversee a $300,000 budget to build out the Operational Risk and Controls metrics across all business lines.
- Communicate assessment results and findings to management and the Operational Risk Board, assist in developing an adequate action plan, track the completion progress, and test resolved issues.
- Supports external auditors by coordinating information requirements.
0-5 years of experience
- Provide Claims Manager with the audit results. Facilitate quality improvements by reporting trends so that errors may be identified and rectified through notification to examiners or retraining when indicated.
- Perform analysis on staff performance to ensure accuracy, provide reports to management based on findings, and making the appropriate actions to ensure the staff meets 97% accuracy.
- Complete supervisor rebuttals.
- Complete managerial reports for the department largest client.
- 2 years’ experience with training/auditing
- Knowledge of claims processes including entry, adjudication for HCFA 1500 & UB-04 claims, COB, and adjustments.
- (5)+ years’ experience within a health insurance administration environment
- Provides hands on training to new and existing employees on industry, client groups, and claim processes, training progress, evaluate effectiveness, and implement changes as needed.
- Proficient in Medical Terminology, provider, and APC & DRG methodologies.
- Excellent written and verbal communication skills.
0-5 years of experience
- Conducts audits of GLP and GMP projects and studies.
- Conducts Quality Systems audits.
- Reports audit findings to management.
- Develops checklists to make audits more efficient.
- Reviews protocols, reports and SOPs.
- Performs all required duties in compliance with company SOPs.
0-5 years of experience
- Reviews analytical data packages including analytical reports, project notebooks, analytical data, customer correspondence, and signed proposals
- Reviews internal records including instrument log books and calibrations
- Responsible for DEA activities
- Maintains instrument calibration and maintenance schedules
0-5 years of experience
- Review and release studies that were performed in compliance to GLP policies
- Audit laboratory studies in process
- Ensure SOPs and quality procedures were followed
- Have knowledge and training on both GLP and cGMP regulations
0-5 years of experience
- Supervise the following areas in the Quality Assurance department: Internal/External Audits; CAPA, Deviations, Complaints, and NonConformances; and Inventory Control/Quality Control and Labeling.
- Perform internal and external audits and responsible for regulatory licenses and FDA inspections.
- Worked and assisted in the implementation of different quality systems (Label Control, Vendor qualification, Training, Internal Audits, product final inspection among a few). Conduct investigations for deviations, nonconformances and complaints. Supervised the Document Control area.
0-5 years of experience
- Monitored calls to ensure that what was said in the conversation was what was on the insurance applications. Completed score cards informing agents superiors of the agents strengths and weaknesses. Little or no micromanagement.
- Review and approve quality plans submitted by contractors.
- Generate and maintain quality control operating budgets.
- Verify that raw materials, purchased parts or components, in-process samples, and finished products meet established testing and inspection standards.
- Review quality documentation necessary for regulatory submissions and inspections.
- Review and update standard operating procedures or quality assurance manuals.
- Produce reports regarding nonconformance of products or processes, daily production quality, root cause analyses, or quality trends.
- Monitor development of new products to help identify possible problems for mass production.
- Identify quality problems or areas for improvement and recommend solutions.
- Instruct staff in quality control and analytical procedures.
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Quality Assurance Auditor
Last edited by: Gabriela Barcenas, CONTENT STRATEGIST -
Gabriela Barcenas
CONTENT STRATEGISTGabriela is a Certified Professional Resume Writer (CPRW) and career adviser. With 10 years of digital media experience and five years of resume writing expertise, her publication history includes fashion, education, travel, social justice, equitable design and career advice.
