Responsible for bulking and filtration container set ups, performs filtrations of bulk materials, and manufactures buffers/stock solutions per manufacturing procedures with limited supervision. Participates in process improvement projects.
Key Responsibilities: • Assist in manufacture of controls and calibrators and complete batch records following cGMPs. • Perform in-process assays using equipment such as spectrophotometers, pH meters and clinical analyzers. • Prep Small parts for washer and autoclave. • Build and change valve diaphragms. • Weighing, transfer, mixing of chemicals required. • Perform product filtrations. • Clean and Steam in place steam steel tanks and transfer lines. • Prepare glassware and steel tanks for sterilization in autoclave and operate autoclave. • Maintain lab equipment including pumps, pH meters, and flow meters. • Keep department lead or manager updated on all issues. • Monitor stocks of common lab supplies. • Performs other job duties as required.
Minimum Requirements/Qualifications: • High school diploma or equivalent. AA degree preferred with some cGMP lab experience. • Basic lab skills and knowledge of safety precautions. • Familiarity with Quality System Regulations. • Experienced working with potentially hazardous chemicals and human source materials. • Must be able to lift 25 lbs routinely. • May be required to lift up to 50 lbs occasionally.
Non-Negotiable Hiring Criteria: • Must be in compliance with GMP, QSRs, ISO and IVD regulations in the performance of department responsibilities. • Ability to read and write English and understand instructions written or orally in English. • Ability to add, subtract, multiply and divide in all units of measure, whole numbers, fractions and decimals. • Knowledge of Word, Excel and Outlook.