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.