Analyst, Quality Control Analytics

Key Responsibilities

• Ensure testing is completed in compliance with all applicable procedures, standards, and current Good Manufacturing Practices regulations.
• Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.
• Work with Process Development team, Quality, and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products.
• Perform peer review/approval of laboratory data.
• Use electronic systems (LIMS, iLAB) for execution and documentation of testing.
• Build, review, and approve relevant QC documents, SOPs, and WIs.

Qualifications

Minimum of a Bachelor's or equivalent University Degree required; focused degree in Biology, Biochemistry, Microbiology, or related scientific field is preferred.

Required

• Minimum 2 years of relevant work experience
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
• Experience performing one or more of the following cellular and/or molecular based techniques: qPCR, ELISA, Cell Culture, and/or Potency assays
• Experience with Manual Sample Processing
• Excellent written and verbal communication skills

Preferred

• Experience in a Quality Control setting
• Experience within Biopharmaceutical or Pharmaceutical industry
• Work experience in Cell and/or Gene Therapy or Biologics
• Experience with LIMs and SAP or equivalent systems

Other

• Requires ability and flexibility to work 10-hour shifts Second Shift (2PM-12AM) Weds-Sat.
• 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