Senior GMP QA Specialist: Pharma Quality & Compliance

Planet Pharma; Cambridge (MA); On-site; USD 76,000 - 83,000; Full time

Job summary

Planet Pharma is seeking an experienced QA professional in Cambridge, MA to oversee quality assurance for drug substance, drug product, and devices. The role involves reviewing batch records, regulatory filings, and production records, while supporting design verification and DHF deliverables.

Candidates should have a BS in life sciences and 5+ years QA GMP experience, with strong knowledge of FDA/EMA regulations. Excellent communication and organizational skills are essential for success.

Qualifications

• BS degree in life sciences, engineering or related field.
• 5+ years pharmaceutical QA experience in GMP manufacturing and supply chain.
• Good understanding of FDA and EMA regulations and guidelines.
• Excellent organizational, communication, and interpersonal skills.

Responsibilities

• Review of event documentation such as Batch records, Exceptions, and Regulatory filings.
• Production record review and Product disposition for drug substance, drug product, device assembly and finished goods.
• Support design development plan including design verification and DHF deliverables.
• Build and maintain Product Specification Files (PSF) for the companies program.

Skills

Regulatory knowledge

GXP regulations

Teamwork

Independent work

Deadline management

Communication skills

Education

BS in life sciences

5+ years GMP QA

FDA/EMA regulations knowledge

Job description

Planet Pharma is seeking an experienced QA professional in Cambridge, MA to oversee quality assurance for drug substance, drug product, and devices. The role involves reviewing batch records, regulatory filings, and production records, while supporting design verification and DHF deliverables.

Candidates should have a BS in life sciences and 5+ years QA GMP experience, with strong knowledge of FDA/EMA regulations. Excellent communication and organizational skills are essential for success.