QA Officer – Bioanalytical Laboratory
Location: Somerset, New Jersey, USA
Position Summary
The QA Officer will ensure the highest quality standards and regulatory compliance within the new bioanalytical laboratory. This role is critical as we execute mock and client studies across small and large molecule platforms, including LC-MS/MS and immunochemistry.
Working closely with scientific teams, the QA Officer will audit, monitor, and continuously improve laboratory processes and quality management systems during a period of rapid growth and technology expansion.
Key Responsibilities

• Audit bioanalytical studies, including LC-MS/MS-based studies, during method validation, sample analysis, and reporting phases to ensure data integrity, regulatory compliance (GLP/GCP), and adherence to SOPs.
  

• Oversee the execution of mock studies in collaboration with laboratory scientists and analysts; document findings and recommend actionable improvements for SOPs, workflows, and the eQMS/LIMS platforms.
  

• Participate in the review, optimization, and ongoing improvement of SOPs and controlled documents as new capabilities (e.g., qPCR, flow cytometry) are brought online.
  

• Support the deployment and validation of the integrated eQMS and LIMS infrastructure, ensuring robust audit trails, secure data capture, and compliant sample management practices.
  

• Review laboratory records, investigation reports, CAPAs, deviations, and change controls; verify proper completion and timeliness according to regulatory requirements.
  

• Serve as a primary QA interface for internal study teams and external sponsors; support regulatory inspections and client audits as needed.
  

• Collaborate cross-functionally with laboratory management, sample management, IT, and project managers to maintain continuous inspection readiness.
  

• Support training programs on regulated laboratory quality systems and best documentation practices.
  

• Monitor compliance with GLP, GCP, GMP, and applicable FDA, EMA, and ICH guidelines.
  

• Assist in vendor qualification activities and the review of laboratory equipment calibration, maintenance, and qualification records.
  

• Track quality metrics and identify trends to support continuous improvement initiatives across laboratory operations.
  

• Participate in risk assessments, root cause investigations, and implementation of corrective and preventive actions (CAPAs).

Qualifications

• Bachelor’s degree or higher in a scientific discipline (e.g., Biochemistry, Chemistry, Biology, Pharmaceutical Sciences) or equivalent experience.
  

• 3+ years of experience in a regulated (GLP, GCP, GMP) bioanalytical laboratory QA role, with hands-on experience auditing LC-MS/MS workflows.
  

• Demonstrated knowledge of bioanalytical method development and validation, biological sample handling and analysis, and regulatory guidelines (e.g., FDA, EMA, ICH M10).
  

• Experience with eQMS and LIMS implementation, validation, and maintenance in a laboratory setting.
  

• Strong analytical, organizational, and communication skills with the ability to collaborate effectively across scientific and operational teams.
  

• Familiarity with immunochemistry, qPCR, and/or flow cytometry platforms is a plus.
  

• Excellent attention to detail, adaptability, and a commitment to continuous improvement.
  

• Proficiency with Microsoft Office and electronic documentation systems.
  

• Ability to manage multiple priorities while maintaining high quality standards in a fast-paced laboratory environment.

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