Compliance Specialist CMC-----Westborough, MA at Zenith LifeScience · Westborough, MA · Joined
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Compliance Specialist CMC-----Westborough, MA
Zenith LifeScience · Westborough, MA · Just now · 0 applicants
NewOn-siteFull-timeMiddle
Pay
Pay not listed
Workplace
On-site
Job type
Full-time
Level
Middle
Team: Quality Assurance · Source: jobright · Posted by joined-scrapper
About the role
Supports GMP and non-GMP manufacturing programs by performing QA reviews of development studies and records, communicating audit results, and collaborating on quality events and documentation for regulatory submissions.
What you’ll do
Perform QA reviews of development studies and records
Communicate review and audit results
Collaborate with stakeholders on quality events and documentation
Support GMP and non-GMP manufacturing programs
Support regulatory submissions
What you’ll need
BS/BA in Life Sciences, Engineering, or Chemistry with 2-3 years QA experience in GMP-regulated industry
Masters degree with 1-2 years experience in lieu of above
Or minimum 6+ years industry experience in biotech/pharma quality, manufacturing, or high-technical aptitude role
Working fluency in Microsoft Office (Excel, PowerPoint)
Demonstrated knowledge of cGMPs for biotechnology, cell therapy, and/or gene therapy
Ability to interpret regulatory rules and make risk-based decisions using Quality-by-Design principles
Original job description
AIRM is seeking a Compliance Specialist CMC, Quality Assurance to support GMP and non-GMP manufacturing programs and regulatory submissions. The role performs QA reviews of development studies and records, communicates review and audit results, and collaborates with stakeholders on quality events and documentation.BS/BA in Life Sciences, Engineering, or…