GMP QA Compliance Specialist for Regulatory Submissions

Planet Pharma; Westborough (MA); In loco; USD 70.000 - 100.000; Tempo pieno

Descrizione del lavoro

Planet Pharma is seeking a Compliance Specialist CMC, Quality Assurance in Massachusetts to perform QA tasks supporting GMP and non-GMP manufacturing and regulatory submissions. The role emphasizes data integrity, quality, and compliance across QA areas.

You will review development studies for submissions, communicate QA results, and collaborate with cross-functional teams to ensure quality records are accurate and well documented.

Competenze

• BS/BA in Life Sciences, Engineering, or Chemistry with 2–3 years QA in GMP-regulated industry, or 1–2 years with a Master.
• In lieu of a Life Sciences degree, 6+ years of industry QA experience with high technical aptitude.
• Proficiency in MS Office (Excel and PowerPoint).

Mansioni

• QA review of development studies for regulatory submissions to ensure compliance.
• Communicate QA review results and reporting to stakeholders.
• Collaborate with cross-functional teams on quality events and records.

Conoscenze

MS Office

Formazione

Bachelor's degree in Life Sciences, Engineering, or Chemistry

Master's degree

Descrizione del lavoro

Planet Pharma is seeking a Compliance Specialist CMC, Quality Assurance in Massachusetts to perform QA tasks supporting GMP and non-GMP manufacturing and regulatory submissions. The role emphasizes data integrity, quality, and compliance across QA areas.

You will review development studies for submissions, communicate QA results, and collaborate with cross-functional teams to ensure quality records are accurate and well documented.