Biopharma Quality Assurance Lot Disposition

Quality Assurance Specialist – Biopharma

Position Summary

We are seeking a detail-oriented and highly motivated Quality Assurance (QA) Specialist to support quality systems, batch release activities, and lot distribution oversight within a regulated biopharmaceutical manufacturing environment. The QA Specialist will ensure products, processes, documentation, and distribution activities comply with current Good Manufacturing Practices (cGMP), regulatory requirements, and company quality standards. This role works cross-functionally with Manufacturing, Quality Control, Supply Chain, Warehouse, Regulatory Affairs, and Validation teams to maintain product quality and ensure compliant product distribution.

Key Responsibilities

• Review and approve batch production records, SOPs, deviations, change controls, CAPAs, and validation documentation.
• Perform lot disposition and support product release activities for commercial and clinical products.
• Coordinate and oversee lot distribution processes to ensure accurate documentation, traceability, and regulatory compliance.
• Verify shipping, storage, labeling, and distribution records for released product lots.
• Ensure compliance with FDA, EMA, ICH, and cGMP regulations throughout manufacturing and distribution operations.
• Conduct quality assurance audits and inspections of manufacturing, warehouse, and distribution activities.
• Support investigations involving deviations, non-conformances, out-of-specification (OOS) results, distribution discrepancies, and customer complaints.
• Maintain lot traceability records and support product recall readiness activities.
• Collaborate with Supply Chain and Logistics teams to ensure proper handling and controlled distribution of temperature-sensitive biopharmaceutical products.
• Monitor and trend quality metrics to identify process improvement opportunities.
• Assist with preparation and support for internal, customer, and regulatory inspections.
• Maintain training compliance and support GMP training initiatives.

Required Qualifications

• Bachelor’s degree in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, Engineering, or related scientific discipline.
• 2–5 years of Quality Assurance experience in biopharmaceutical, pharmaceutical, biotechnology, or medical device industries.
• Strong knowledge of cGMP, GDP (Good Distribution Practices), FDA regulations, and quality systems.
• Experience with batch review, lot release, and distribution documentation.
• Familiarity with deviation management, CAPA systems, change control, and product traceability requirements.
• Strong attention to detail and organizational skills.
• Excellent written and verbal communication abilities.
• Proficiency with Microsoft Office and electronic quality management systems (eQMS).

Preferred Qualifications

• Experience supporting biologics, sterile manufacturing, cell/gene therapy, or cold-chain distribution operations.
• Knowledge of inventory control, warehouse quality systems, and serialization/track-and-trace processes.
• Experience with ERP or quality systems such as SAP, TrackWise, Veeva, or MasterControl.
• ASQ Certified Quality Auditor (CQA) or related certification preferred.
• Experience supporting regulatory inspections and audits.

Key Competencies

• Regulatory compliance and quality mindset
• Attention to detail and accuracy
• Investigation and problem-solving skills
• Cross-functional collaboration
• Documentation and organizational excellence
• Accountability and integrity

Work Environment

• Combination of office, warehouse, manufacturing, and laboratory environments.
• May require gowning for GMP manufacturing or controlled storage areas.
• Occasional evening, weekend, or audit support may be required.