QA Specialist: Drug Product Release & Compliance

AbbVie Inc.; Waltham (MA); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie Inc. is seeking a QA Specialist responsible for reviewing and releasing semi-finished and finished drug products. The role ensures compliance with SOPs and cGMP, and involves quarantine, disposition, and batch record maintenance for global markets.

The candidate will utilize SAP, Trackwise and Maximo, demonstrating independent judgement and strong documentation skills. A Bachelor’s degree in a science or technical field is required, with several years in GMP environments.

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.
• Experience with SAP/Maximo/Trackwise is preferred.

Responsibilities

• Review and release of semi-finished and finished drug products.
• Ensure compliance with cGMP, ISO requirements and SOPs.
• Quarantine and disposition of products and maintenance of batch records.
• Prepare batch disposition documents for international markets as required.

Skills

Quality Assurance

Documentation review

Regulatory compliance

GMP knowledge

Analytical thinking

Education

Bachelor’s Degree in the Sciences or technical field

Tools

SAP

Maximo

Trackwise

Job description

AbbVie Inc. is seeking a QA Specialist responsible for reviewing and releasing semi-finished and finished drug products. The role ensures compliance with SOPs and cGMP, and involves quarantine, disposition, and batch record maintenance for global markets.

The candidate will utilize SAP, Trackwise and Maximo, demonstrating independent judgement and strong documentation skills. A Bachelor’s degree in a science or technical field is required, with several years in GMP environments.