Quality Assurance (QA) Specialist II

About the role

The Quality Assurance (QA) Specialist II will support the Global Biologics Quality Function within Operations, ensuring product compliance throughout the lifecycle. This position requires a detail‑oriented professional who can balance high quality standards with operational efficiency.

Key responsibilities

• Provide QA oversight of biologic products, ensuring adherence to cGMP, regulatory requirements, and internal quality systems.
• Support quality‑related activities such as product transfers, continuous improvement projects, and cross‑functional initiatives.
• Manage change control records, including impact assessments, implementation, documentation, and effectiveness verification.
• Perform documentation, batch record, and data reviews in line with ALCOA+ data integrity principles and Good Documentation Practices.
• Oversee document management processes: creation, review, approval, revision control, and archival of controlled quality documents.
• Utilize quality and business systems (SAP, OneTrack, TrackWise, OneVault, etc.) to maintain compliant operations.
• Communicate with management and cross‑functional stakeholders on quality initiatives, manufacturing activities, and regulatory commitments.
• Ensure ongoing compliance with quality systems, support inspection readiness, and assist with audit preparation.

Required profile

• Bachelor’s degree in Physical or Life Sciences, Pharmacy, Engineering, or a related field.
• Minimum 2 years of combined experience in manufacturing, QA, or R&D within pharmaceutical, biologics, device, or chemical industries.
• Familiarity with statistical quality systems, electronic document management, and laboratory information management.
• Strong knowledge of cGMP and related regulatory requirements.
• Excellent oral and written communication skills.

Required skills

• SAP
• OneTrack
• TrackWise
• OneVault
• ALCOA+ data integrity principles
• Good Documentation Practices (GDP)
• Statistical quality systems
• Electronic document management
• Laboratory information management systems (LIMS)