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Description:
- Execute quality oversight of manufacturing clinical and US commercial finished goods assembly/packaging/labeling up through lot disposition to include review and approval of Deviations, Change Controls, CAPAs.
- Provide quality oversight of our external clinical and US commercial finished goods manufacturing network quality management systems, ensuring compliance with regulations in all relevant markets.
- Perform data migration activities in support Product Specification File expansion.
Skills:
Quality assurance, change control, deviation, CAPA, batch record review, GMP, audit, clinical, quality operations
Additional Skills & Qualifications:
Minimum BS degree in life sciences
Three (3) to five (5) years of relevant QA work experience in a regulated industry
Experience of first hand GMP management is preferred, and will include exposure to FDA or other authorities of similar standing.
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.
