QA Associate III: Quality & Compliance Champion

Biogen, Inc.; Northern (KY); Hybrid; USD 69,000 - 90,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Vacation and holidays

Job summary

Biogen, Inc. is seeking a QA Associate III to apply strong knowledge of cGMP requirements and Biogen Quality Systems to support compliant manufacturing operations.

You will review and approve documentation that supports batch and cell bank disposition, assess product acceptability for continued processing or distribution, and provide timely quality direction on the manufacturing floor. This role requires sound judgment and the ability to work independently while collaborating with Quality,

Qualifications

• 2+ years of experience in a quality GMP biopharma or pharma environment.
• Working knowledge of GxP regulations and cGMP requirements.
• Strong understanding of quality systems and manufacturing processes.

Responsibilities

• Review and approve batch and cell bank disposition documentation for cGMP compliance.
• Review executed BPRs, PRCDs/WIs, formulas, recipes, validity rules, MPRs, MSLRs, MSMs, PCDs, PFDs and PARs.
• Perform manufacturing-floor record reviews, observations and inspection-readiness walkthroughs.
• Provide quality oversight and regulatory/compliance guidance to manufacturing operations.

Skills

GxP knowledge

cGMP experience

Regulatory knowledge

Quality focus

Documentation review

Communication skills

Education

Bachelor’s Degree in life sciences

Job description

Biogen, Inc. is seeking a QA Associate III to apply strong knowledge of cGMP requirements and Biogen Quality Systems to support compliant manufacturing operations.

You will review and approve documentation that supports batch and cell bank disposition, assess product acceptability for continued processing or distribution, and provide timely quality direction on the manufacturing floor. This role requires sound judgment and the ability to work independently while collaborating with Quality,