Supervisor, Formulation and Fill - 2nd shift

Job description

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