QA Release Specialist — GMP & Compliance Expert

Allergan; Waltham (MA); On-site; USD 85,000 - 120,000; Full time

Job summary

You will quarantine on-hold products, prepare batch disposition documentation for international sites, and perform final sign-off with independent judgement.

Requires a Bachelor’s in science or technical field, 5 years in quality, GMP experience, and familiarity with SAP, Maximo, and Trackwise.

Qualifications

• Bachelor’s degree in sciences/technical field or equivalent experience.
• 5 years of experience in a quality role or reviewing documentation records.
• GMP/cGMP, ISO 13485 knowledge preferred.
• SAP experience preferred; familiarity with Maximo and Trackwise.

Responsibilities

• Perform QA review and release of semi-finished and finished drug products.
• Review batch records to support release schedules and regulatory compliance.
• Quarantine and monitor on-hold products 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.
• Perform final product disposition and sign-off per SOPs; exercise independent judgement.
• Apply independent judgement and critical thinking in batch assessments.

Skills

Quality Assurance

Independent judgement

Documentation review

Education

Bachelor’s Degree in Sciences or technical field

Tools

SAP

Maximo

Trackwise

Job description

You will quarantine on-hold products, prepare batch disposition documentation for international sites, and perform final sign-off with independent judgement.

Requires a Bachelor’s in science or technical field, 5 years in quality, GMP experience, and familiarity with SAP, Maximo, and Trackwise.