Analyst Quality Control, Analytics

The QC Analyst is responsible for conducting biochemical, microbiological, and/or general testing of final product samples submitted to the QC laboratories, ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. They typically work with a team of 5-15 other Analysts within the functional laboratory of the Quality Control department.

Key Responsibilities

• Perform analytical testing and maintain a safe work environment in compliance with all applicable procedures, EHS, and GMP regulations
• Perform peer review/approval of laboratory data and logbooks
• Use electronic systems (e.g., LIMS, iLAB) for execution and documentation of testing
• Build, review, and approve relevant QC documents, SOPs, and WIs
• Complete invalid assay and general laboratory investigation records, CAPAs, change controls
• Support Health Authority inspections
• Provide input to functional laboratory meetings

Qualifications

Education: Minimum of a Bachelor's or equivalent University Degree required; advanced degree (MSc., Ph.D.) or focused degree in Biology, Biochemistry, Chemistry, or related scientific field is preferred.

Required Experience and Skills

• Minimum of two (2) years of relevant work experience
• Experience performing one or more of the following cellular and/or molecular based techniques: qPCR, Flow Cytometry, ELISA, Cell Culture, and/or Potency assays
• Experience within Biopharmaceutical or Pharmaceutical industry
• Experience with aseptic processing in biosafety cabinets and/or ISO 5 clean room
• Demonstrated experience successfully working in an analyst role/level and proficiency using analytical methodologies within a functional laboratory
• Knowledge of cGMP regulations and Good Documentation Practices (GDP)
• Experience with Quality Control document reviews and regulatory inspection processes
• Proficient in performing technical writing (e.g., test methods, SOP's, protocols, etc.)
• Excellent written and verbal communication skills

Preferred Experience and Skills

• Work experience in Cell and/or Gene Therapy or Biologics
• Basic knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards
• Experience with LIMs and SAP or equivalent systems
• Experience, training, or certification with Process Excellence tools and methodologies

Other Requirements

• Requires ability and flexibility to work 10-hour shifts between the operational hours of 8:00am - 6:00pm (Sunday - Wednesday), and provide occasional support on the weekends or other shifts
• Requires the ability to meet the physical demands (lift up to 20 lbs, stand or sit for extended periods of time in a laboratory setting), to perform visual inspections of materials (color, appearance, particles, etc.), and to document observations during laboratory testing
• Requires up to 5% domestic travel to other sites/locations