QA Compliance Specialist: GMP & Regulatory Submissions

Zenith LifeScience; Westborough (MA); On-site; USD 65,000 - 75,000; Full time

Job summary

Zenith LifeScience LLC. in Westborough, MA is seeking a Compliance Specialist CMC to support QA activities for GMP-regulated manufacturing programs and regulatory submissions.

The role emphasizes data integrity, quality, and compliance across QA areas and collaboration with cross-functional teams to ensure high standards. The candidate will review development studies, manage QA communications, and work with stakeholders to document quality events and deviations in a regulated environment.

Qualifications

• BS/BA in Life Sciences, Engineering, or Chemistry with 2–3 years QA in GMP-regulated industry.
• MS degree may count for 1–2 years experience in lieu of Life Sciences degree.
• 6+ years in biotech/pharma QA acceptable in lieu of degree depending on experience.

Responsibilities

• Performs QA review of development studies for regulatory submissions.
• Communicates QA review results and findings.
• Collaborates with cross-functional teams to document quality events and deviations.

Skills

Data integrity

QA documentation

Education

BS/BA in Life Sciences, Engineering, or Chemistry

Tools

Microsoft Office Suite (Excel, PowerPoint)

Job description

Zenith LifeScience LLC. in Westborough, MA is seeking a Compliance Specialist CMC to support QA activities for GMP-regulated manufacturing programs and regulatory submissions.

The role emphasizes data integrity, quality, and compliance across QA areas and collaboration with cross-functional teams to ensure high standards. The candidate will review development studies, manage QA communications, and work with stakeholders to document quality events and deviations in a regulated environment.