QA Specialist: GMP Release & Batch Compliance

Biopharma Careers; Waltham (MA); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Job summary

AbbVie is seeking a QA Specialist in the United States to review and release semi-finished and finished drug products, ensuring adherence to cGMP and SOPs. You will quarantine and monitor on-hold products, and prepare batch disposition documentation for international markets.

The role requires a sciences degree, 5 years of quality experience, GMP exposure, and familiarity with SAP/Maximo/Trackwise. AbbVie offers a comprehensive benefits package and room for career growth.

Qualifications

• Bachelor’s degree in the sciences or technical field or equivalent experience.
• 5 years of experience in a quality role or experience handling and reviewing documentation records.
• 3 years of experience in a GMP environment.
• SAP experience preferred; familiarity with ISO 13485, CMDRs, and EMEA regulations preferred.

Responsibilities

• Perform QA review and release of semi-finished and finished products.
• Review batch records to support release schedules and regulatory compliance.
• Quarantine and monitor products on hold prior to disposition.
• Prepare batch disposition documentation for international markets.
• Identify and resolve batch record discrepancies to prevent regulatory impact.
• Assist in maintaining dispositioned batch records for secure storage and retrieval.
• Sign off on final product release to the market.
• Exercise independent judgement and critical thinking in batch reviews.

Skills

Quality experience

Documentation review

Independent judgement

Education

Bachelor’s Degree in Sciences or technical field

Tools

SAP

Maximo

Trackwise

Job description

AbbVie is seeking a QA Specialist in the United States to review and release semi-finished and finished drug products, ensuring adherence to cGMP and SOPs. You will quarantine and monitor on-hold products, and prepare batch disposition documentation for international markets.

The role requires a sciences degree, 5 years of quality experience, GMP exposure, and familiarity with SAP/Maximo/Trackwise. AbbVie offers a comprehensive benefits package and room for career growth.