QA Associate III: cGMP Compliance & Quality Impact

Biogen, Inc.; North Carolina; On-site; USD 69,000 - 90,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Tuition reimbursement

Paid vacation

Job summary

Biogen is seeking a QA Associate III to support compliant manufacturing operations, review batch and cell bank disposition, and provide quality direction on the floor. You will partner across Quality, Manufacturing and PO&T to resolve issues, support NPI transfers, and contribute to CAPA and regulatory readiness.

The role requires a Bachelor’s Degree in life sciences and 2+ years of GMP-biopharma experience, with strong knowledge of GxP, cGMP, and documentation standards.

Qualifications

• Bachelor’s Degree in life sciences or related field required.
• Minimum 2+ years of experience in quality GMP biopharma or pharma.
• Working knowledge of GxP regulations, cGMP requirements and FDA/EMA expectations.
• Understanding of quality systems and manufacturing processes.

Responsibilities

• Review and approve batch and cell bank disposition documentation for cGMP compliance.
• Review regulatory documents and manufacturing records for quality compliance.
• Conduct manufacturing-floor reviews and inspection-readiness activities.
• Provide technical writing and investigation support including root cause analysis.

Skills

GxP knowledge

cGMP understanding

Strong communication

Education

Bachelor’s Degree in Life Sciences

Job description

Biogen is seeking a QA Associate III to support compliant manufacturing operations, review batch and cell bank disposition, and provide quality direction on the floor. You will partner across Quality, Manufacturing and PO&T to resolve issues, support NPI transfers, and contribute to CAPA and regulatory readiness.

The role requires a Bachelor’s Degree in life sciences and 2+ years of GMP-biopharma experience, with strong knowledge of GxP, cGMP, and documentation standards.