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Description:
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.
Additional Skills & Qualifications:
Bachelor’s degree strongly preferred; Degree in Biology, Chemistry or related field of study preferred
3 – 5 years of experience in a FDA regulated pharmaceutical facility preferred
3 – 5 years of experience in Quality Assurance / Quality Systems
Ideally 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
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
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- 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
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
