The Quality Control Analyst II performs routine and advanced quality testing of raw materials, in-process, and final products in a cGMP environment, ensuring compliance with SOPs and validation protocols.
They assist in developing and optimizing test methods, review data, troubleshoot assays and instruments, and contribute to documentation such as SOPs and protocols.
Additional responsibilities include environmental monitoring, water and utility testing, biological indicator and endotoxin testing, microbial identification, and participating in equipment qualification and special microbiology studies.
They maintain lab safety, cleanliness, and equipment, support investigations of OOS results, and perform sample management and data entry in LIMS.
Qualifications include an associate's degree with 7+ years or a bachelor's degree with 3-6 years industry experience, with preferred knowledge of aseptic techniques and proficiency in data management tools.