Job Summary This position is a 2nd shift role, 1:30PM - 10:00PM. Supervise and perform regularly the preparation, formulation and dispensing of pharmaceutical products according to our current Good Manufacturing (cGMPs) and utilize Standard Operating Procedures (SOPs) in a clean room environment. Write and complete investigations, CAPAs, deviations and change controls utilizing root cause analysis tools and reporting software. Area Of Responsibility • Supervise and perform the activities of technicians on the second shift in equipment and component preparation operations; dispensing API and excipients; formulation and filling and capping of parenteral drug products. Also responsible for overseeing the formulation and filling of dermatological drug products. • Schedule weekly plan of floor activities for technicians on second shift • Author and track to close investigations, CAPAS, deviations and change controls as required • Troubleshoot and solve moderate to complex problems related to the equipment, processes; existing or new products • Oversee inventory control in the production area and order supplies as needed for production to assure no delay in the manufacturing plan • Use systems like SAP, Track Wise, EDMS etc. • Evaluate team performance by conducting midyear and yearly reviews • Review completed batch records to ensure product is made in accordance with specifications • Review SOPs and Batch Records, and update through DCRs as needed • Work under limited supervision and follows clearly described procedures • Other duties as assigned • Education in Life sciences or technical discipline Work Conditions: • Lab • Clean room/controlled classified areas • Manufacturing/production areas • Office • Exposure to noise • Exposure to Chemical/Biological hazards • Exposure to non-hazardous chemicals • Exposure to radiation within NRC limits • Exposure to/use of syringes and needles • Must wear scrubs/coveralls, safety glasses, safety shoes, gloves as required Physical Requirements: • Stand, walk, sit, use hands and fingers to handle or feel, reach or push with hands and arms, stoop, kneel, crouch or crawl, climb, talk and hear • Able to operate lab equipment, production equipment and computer/office machines • Ability to wear Personal Protection Equipment • Lift up to 50 lbs. Travel Estimate Up to 0% Education and Job Qualification • Bachelor's degree in related field or equivalent experience • 6 to 8 years of experience in pharmaceutical manufacturing • Excellent verbal, written and interpersonal communication skills • High level of initiative and self-motivation • Strong computer skills • Attention to detail • Ability to plan, prioritize and organize diversified workload • Team management skills • Record keeping skills • Safe chemical handling techniques • Knowledge of SAP, GMP, GDP, FDA, and OSHA regulations and standards Experience • Minimum 2 – 5 years of supervisory or team lead experience • 5 to 7 years of aseptic processing and aseptic area techniques experience • Experience with technical writing, root cause analysis and completing investigations, CAPAs, deviations and change controls