QC Specialist (Data Review & Investigations)

Key Responsibilities - Data Review & Documentation

• 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. 

Key Responsibilities - Investigations & Deviations:

• 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. 

Education and Experience:

• 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.