Quality Control Laboratory Analyst (Raw Materials)

Role: Quality Control Analyst responsible for in-house raw materials and product testing in gene therapy manufacturing. Responsibilities: conduct cGMP material inspections and testing, review analytical data for compliance, support laboratory investigations, develop and update QC documentation (SOPs, specifications, methods), support document control and record retention, implement USP quality standards, maintain QC equipment through qualification and calibration. Requirements: Bachelor's in life sciences or related field; experience with pH, osmolality, endotoxin, appearance, media, cell culture, FBS testing preferred; strong laboratory background with ability to follow SOPs; proactive, motivated, excellent scientific writing and communication skills; proficient in MS Office. High-Value: in-house QC testing for clinical and commercial gene therapy products, cGMP environment, emphasis on regulatory compliance and documentation, supporting GMP manufacturing. WorkSetup: not specified; the role is based at Krystal's Pittsburgh location.