Description

Perform bioanalytical quality testing, investigate out-of-specification results, and ensure compliance with GMP and GLP standards.

This role is on-site.

Responsibilities

• Execute and approve bioanalytical testing events within STARLIMS and SAP systems.
• Investigate out-of-specification (OOS) and out-of-tolerance (OOT) results and support CAPA activities.
• Maintain laboratory documentation, quality records, sample storage, and testing inventory.
• Support product development, stability studies, validation activities, and troubleshooting initiatives.
• Ensure compliance with GMP, GLP, EHS, and quality system requirements during internal and external audits.

Required Skills

• Bachelor’s degree in Biology, Chemistry, Biochemistry, Microbiology, Biotechnology, or a related scientific discipline.
• 3-4 years of laboratory quality assurance, quality control, or bioanalytical testing experience in healthcare, diagnostics, medical device, biotechnology, or pharmaceutical environments.
• Hands-on experience with STARLIMS and SAP laboratory systems.
• Proficiency in HPLC for bioanalytical testing.
• Experience with CAPA investigations, OOS/OOT investigations, and quality record management.
• Knowledge of stability testing, method validation, and technical troubleshooting.
• Understanding of diagnostic product testing, diagnostic methods, and laboratory quality systems.

Key Skills

Education

Bachelor's degree