Description

Key Responsibilities:

 

• Perform bioanalytical quality testing and evaluate results for conformance to established specifications.
• Execute and approve 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, process improvement, stability studies, validation activities, and troubleshooting initiatives.
• Ensure compliance with GMP, GLP, EHS, and quality system requirements.
• Participate in internal and external audit readiness activities.
• Monitor laboratory processes and contribute to continuous improvement initiatives.
• Maintain training compliance through learning management systems and laboratory certification programs.
• Serve as a laboratory SME and support daily operational activities with minimal supervision. 
  
   

Education

 

• 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 within healthcare, diagnostics, medical device, biotechnology, or pharmaceutical environments. 
  
   

Required Skills

 

• Hands-on bioanalytical testing experience with:
• Experience using STARLIMS and SAP laboratory systems.
• CAPA investigations, OOS/OOT investigations, and quality record management.
• GMP and GLP compliance in regulated laboratory environments.
• Stability testing, method validation, and technical troubleshooting.
• Knowledge of diagnostic product testing, diagnostic methods, and laboratory quality systems.
• Internal and external audit support experience.
• Laboratory inventory management and sample storage controls.
• Quality system documentation and compliance management

Key Skills

Education

Bachelor's degree