QA Specialist II

Job Title

QA Specialist

Onsite

$35–$37/hr.

6 Months

The QA Technician is responsible for bioanalytical quality assurance testing and quality system support within laboratory operations. This role performs testing activities, reviews analytical data for specification compliance, supports CAPA investigations, maintains testing and product inventory, and ensures adherence to GMP, GLP, and quality system requirements.

The position operates in a fast-paced laboratory environment and serves as a subject matter expert (SME) for certified testing methods.

• 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.

• 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.

• Hands‑on bioanalytical testing experience with:
  • HPLC
  • SDS‑PAGE
  • Western Blot
  • Dot Blot
  • ELISA
  • Mass Spectrometry (MS)
  • Microtiter Plate Assays
• 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.