Sr. QA Compliance Analyst - Bedford, United States - Actalent

Actalent Bedford, United States

3 days ago

Full time

Description

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 @

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 for other accommodation options.

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