- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
QA Specialist - Saint Louis, United States - Actalent
Description
Description:
Quality Assurance Specialist – Quality Systems, supports all quality system elements to assure compliance with FDA cGMP and other quality standards, with primary responsibilities in Annual Product Reviews, Change Controls, and Product Labeling Changes. Provide quality oversight for the creation and revision of labeling components, including participation on the Label Review Team.Compile data and write Annual Product Reviews.Support of the Change Control Process, including participation on the Change Control Review Board.Support training program, including New Employee Orientation Program and annual GMP training schedule.Provide necessary documentation to Regulatory Affairs, as requested (i.e., in support of MCSRs).Review regulatory filings and submissions, as requested.May also participate in other Quality Systems responsibilities including: Tracking and Trending of Quality Data, Training, Supplier Quality Management, as well as internal and external audits. Support site Data Integrity requirements.Provide metrics for Quality Review Board, as requested.Provide support during HACCP, FDA and other inspections.Support Supplier Qualification Program.Support updates to the Approved Vendor/Supplier list.Perform Internal and External Audits per annual audit schedules.
Skills:
Quality assurance, Annual product review, label, change control, Gmp, Fda, quality systems management, pharmaceutical, Audit
Top Skills Details:
Quality assurance,Annual product review,label,change control,Gmp
Additional Skills & Qualifications:
Bachelor's degree strongly preferred; Degree in Biology, Chemistry or related field of study preferred3 – 5 years of experience in a FDA regulated pharmaceutical facility preferred3 – 5 years of experience in Quality Assurance / Quality SystemsIdeally will have exposure and experience with one of the primary areas of responsibility (supporting Label Changes, Change Controls, APR's)Must have demonstrated QA review experience preferably with labels or product information inserts OR writing experience within MS Word and data analysis with Excel
Experience Level:
Intermediate Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
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