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Quality Consultant Resume Samples
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0-5 years of experience
- Responsible for coordinating compliance activities and audits by working with client’s nonclinical groups and other related functional team members and contract auditors.
- Provided GCLP/GCP auditing support by performing audits of nonclinical laboratory facilities, nonclinical reports and data and Certificates of Analyses generated by an analytical laboratory
- Evaluated significance of audits findings and coordinate the findings response with client departments, nonclinical facilities, CROs and/or clinical investigational sites
- Periodically perform clinical site audits, CRO evaluations/audits, clinical system audits, master files audits and clinical document audits
- Review clinical documents including protocols, amendments, sample case report forms, and sample informed consent forms for adequacy and compliance.
0-5 years of experience
- Validation QA lead on three regulated SDLC and software validation business critical projects.
- Created and managed software development validation and control processes.
- Provided company-wide Quality Assurance improvements.
- Project Management using Microsoft project management.
- Developed new procedures, forms, and templates for software design and process validation.
- Created the Software Vendor Compliance (audit) Checklist and performed supplier audits.
- Developed Internal Monsanto Software Audit Checklist and assessed the compliance of 23 projects to 21 CFR 820, 210/211, GAMP 4, and Part 11.
- Implemented document control processes.
- Create a software validation quality system processes of regulated processes.
0-5 years of experience
- Collaborated with cross functional teams in determining requirements for product testing.
- Completed test planning including test cases for use by local and offshore teams.
- Worked closely with development and QA teams in disseminating information on upcoming tests via functional document walkthroughs, demonstrations and test plan / test case reviews.
- Work with and support User Acceptance Test teams after completion of functional test execution.
- Defect management duties included follow up with developers to provide information to expedite defect closure.
- Worked in various database instances using SQL queries and forms within Oracle EBS.
0-5 years of experience
Performed functional, regression smoke, ad-hoc, mobile, cross browser and data migration testing for Salesforce and Microsoft Dynamics for clients within various segments of the industry. Received Microsoft Dynamics system admin Certification which proved to have a successful track record when testing System Admin tools in Dynamics. Also Tested Salesforce System Admin tools as well.
- Performed SQL Queries to verify and test data migration
- Created and executed detailed test plans and test cases
- Performed Functional, UAT, Integration testing throughout many projects
- Worked in an Agile/Scrum and Waterfall environment (based on clients’ needs)
- Took part in stand-up meetings
- Had weekly meetings with the manager to provide updates on projects and provide feedback
- Responsible for update, create, and maintain team documentation
- Hosted Test Plan review meeting with entire project team to ensure the client requirements are being thoroughly met
- Created Test Plans from Functional Specifications Document
0-5 years of experience
- Provide Case Management to at risk homeless population via HUD grant
- Research and secure grant funding for non-profit partners to assist our community’s homeless population
- Provide quality consultation as a clinical expert
- Partner with health care organizations and local businesses to assess and improve quality outcome and effective cost utilization of resources
- Conduct facility audits to ensure partner compliance with all regulatory agencies
- Collect, analyze and develop action plans using six-sigma methodology and communicate findings stakeholders
- Develop process maps, clinical pathways, policies, procedures and training manuals to ensure alignment with organizational goals and regulatory guidelines
- Provide onsite team training on compliance, policies, procedures, team building, quality tools and 5s implementation.
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[Quality Consultant]
Last edited by: Gabriela Barcenas, CPRW, Content Writer II -
Gabriela Barcenas
CPRW, Content Writer IIGabriela 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.
