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Great opportunity to get your foot in the door with one of the top Biotech companies in the Bedford, MA area!
If interested, please reach out directly to Lindsee Allienello at lallienello @ actalentservices.com
Description:
- Perform batch record review
- Run deviations and investigations
- Manage the CAPA and Change Control programs
- Perform QA review of new and revised procedures, technical protocols, validations and reports
- Perform internal and external audits as assigned including internal Quarterly Walkthroughs
- Provide document control support.
- Issue and reconcile batch records
Preferred Skills:
Quality assurance, batch record review, deviations, capas, change control, audit, iso 13485, root cause analysis, SAP, FDA 21 CFR
Additional Skills & Qualifications:
- BS in the life sciences
- 5+ years industry experience in QA
- Knowledge of GMP/ISO requirements, specifically current ISO 13485 Medical Devices.
Experience Level:
Expert 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
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.
