QC Specialist; Data Review & Investigations

The QC Specialist (Data Review & Investigations) is responsible for supporting Quality Control laboratory operations through comprehensive data review, laboratory investigations, deviation management, and GMP documentation activities in a Cell & Gene Therapy environment. This role ensures laboratory testing, data integrity, and documentation comply with current GMP regulations, internal procedures, and regulatory expectations.

The individual will work cross-functionally with QC, QA, Manufacturing, MSAT, and Validation teams to support clinical and commercial manufacturing activities.

• Perform detailed reviews of analytical and microbiological laboratory data for accuracy, completeness, compliance, and data integrity.
• Review laboratory notebooks, worksheets, electronic records, chromatographic data, calculations, and supporting documentation.
• Ensure compliance with cGMP, GDP, ALCOA+, and internal procedures.
• Support review and approval of:

• Raw Materials data
• In-process testing
• Release testing
• Stability testing
• Method transfer documentation
• Qualification and validation protocols/reports

• Verify laboratory investigations, deviations, and OOS/OOT documentation are scientifically sound and properly documented.
• Support batch disposition activities through timely QC documentation review.

• Lead and/or support laboratory investigations including:

• OOS (Out of Specification)
• OOT (Out of Trend)
• Deviations
• Invalid Assays
• Atypical Results
• CAPAs

• Conduct root cause analysis using scientific and risk-based approaches.
• Collaborate with cross-functional teams to identify corrective and preventive actions.
• Track investigation timelines and ensure closure within established metrics.
• Support implementation and effectiveness checks of CAPAs.

• Bachelor’s degree in Biology, Microbiology, Biochemistry, Chemistry, Biotechnology, or related scientific discipline. Advanced degree is a plus.
• Minimum 3-5 years of GMP Quality Control experience in biotechnology, pharmaceutical, or Cell & Gene Therapy industry.
• Experience with laboratory investigations, deviation management, and GMP data review required.
• Experience supporting clinical and/or commercial manufacturing environments preferred.
• Familiarity with Cell & Gene Therapy processes and aseptic manufacturing preferred.
• Strong attention to detail and organizational skills.
• Excellent written and verbal communication skills.
• Ability to work in a fast-paced GMP environment.
• Strong collaboration and teamwork mindset.
• Ability to prioritize multiple assignments and meet timelines.
• Problem-solving and critical-thinking capabilities.

We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.