Quality Assurance (QA) Consultant /Auditor – Bioanalytical Laboratory

Redmond, WA

Essential Duties and Responsibilities: 

We are seeking an experienced Quality Assurance (QA) Consultant/Auditor with a strong background in auditing regulated bioanalytical studies, specifically those involving ELISA assays and LC-MS/MS assays, to ensure compliance with regulatory guidelines. The ideal candidate will have at least 5 years of experience in a bioanalytical laboratory environment, with a comprehensive understanding of FDA regulations and other applicable global regulatory requirements for the conduct of regulated studies.

The QA Auditor will be responsible for auditing bioanalytical studies, ensuring that ELISA and LC-MS/MS assays are conducted according to Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and other relevant industry standards. This role requires a detail-oriented, proactive professional with a deep understanding of the FDA regulations, quality systems, and bioanalytical testing processes.

Key Responsibilities:

1. Audit Execution:

• Conduct internal and external audits of bioanalytical studies, specifically for ELISA assays and LC-MS/MS assays, to ensure compliance with FDA regulations, GLP, GCP, and other relevant guidelines (e.g., EMA, ICH, ISO).
• Review study protocols, test methods, and reports for adherence to regulatory standards and ensure all data is accurate, complete, and reliable.
• Evaluate laboratory procedures, records, and data to ensure alignment with industry standards and regulatory requirements.
• Assess adherence to laboratory documentation and record-keeping practices, including chain-of-custody, equipment calibration, and maintenance records.

2. Regulatory Compliance:

• Ensure the laboratory’s bioanalytical studies comply with FDA 21 CFR Part 58 (GLP), FDA 21 CFR Part 320, FDA 21 CFR Part 312, and FDA 21 CFR Part 11 (Electronic Records) as applicable.
• Review compliance with Good Clinical Laboratory Practice (GCLP) for the validation and calibration of instruments, including those used for ELISA and LC-MS/MS.
• Verify that all study documentation (including batch records, raw data, and final reports) meets regulatory requirements for data integrity, traceability, and transparency.
• Stay current on changes to regulatory guidelines and help interpret these updates to the team.

3. Audit Documentation & Reporting:

• Provide detailed and thorough audit reports, highlighting non-conformances, deviations, and areas for improvement.
• Review audit findings with the laboratory management team and facilitate corrective and preventive actions (CAPA) for any identified gaps in compliance.
• Track CAPA implementation and effectiveness, ensuring timely resolution of audit findings.
• Collaborate with study teams to ensure that corrective actions are appropriately documented and implemented to prevent future non-compliance.

4. Risk Management and Mitigation:

• Identify and assess potential risks associated with study conduct, methodology, and documentation in regulated studies.
• Recommend improvements to QA processes and ensure consistent risk mitigation strategies are in place to comply with regulatory requirements.

5. Training and Support:

• Provide ongoing training and guidance to laboratory staff on GLP, GCP, and other regulatory requirements relevant to ELISA and LC-MS/MS assays.
• Support the development and implementation of quality systems, standard operating procedures (SOPs), and audit protocols.
• Foster a culture of continuous quality improvement by leading or participating in internal audits and inspections.

6. Inspection Readiness:

• Prepare for and support external regulatory inspections (e.g., FDA, EMA, or other regulatory bodies), ensuring all documentation and laboratory practices are always audit-ready.

Qualifications:

1. Education:

• Bachelor’s degree in Life Sciences, Chemistry, Biochemistry, or a related field. A master’s degree is a plus.

2. Experience:

• A minimum of 5 years of experience in a bioanalytical laboratory, with at least 3 years in a QA or audit role focusing on regulated studies.
• Hands-on experience with the validation and auditing of ELISA assays and LC-MS/MS assays in a regulated environment.
• Solid understanding of FDA regulations (21 CFR Part 58, 312, 320, 11), GLP, GCP, GMP, and relevant industry standards (e.g., ISO, ICH guidelines).
• Experience auditing regulated studies in bioanalysis, clinical trials, or pharmaceutical development.
  

3. Knowledge and Skills:

• In-depth understanding of regulatory requirements for bioanalytical testing, particularly for immunoassays (ELISA) and mass spectrometry-based assays (LC-MS/MS).
• Knowledge of data integrity, laboratory documentation practices, and quality control systems.
• Excellent written and verbal communication skills, with the ability to document findings clearly and effectively.
• Strong attention to detail and ability to evaluate complex data and reports.
  
• Proficiency with audit management software, LIMS systems, and Microsoft Office Suite. Familiarity with Watson LIMS or similar bioanalytical LIMS software is preferred.
  
• Ability to work independently and collaboratively within cross-functional teams.
  

The hourly pay for this position is $100-250/hour, reflecting our commitment to fair compensation for the skills and expertise required.
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SystImmune is an Equal Opportunity Employer. Interested applicants should send their CV and cover letter to [email protected]

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