Work Schedule

10 hr shift/nights

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Will work with hazardous/toxic materials

Job Description

Position Summary: Senior Formulation role Manufactures buffers and simple bulk reagents per manufacturing procedures with limited supervision. Participates in process improvement projects. Key Responsibilities: • Responsible for reviewing all area documents. • Responsible for the WNS. • 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. • Weighing, transfer, mixing of chemicals required. • Perform product filtrations. • Clean and steam steel tanks (CIP) / (SIP). • 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. • Responds to Emergency notifications. • Flexible hours and on weekends. Minimum Requirements/Qualifications: • High school diploma or equivalent. AA degree preferred with at least 2 years of 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.