Supervisor, Formulation and Fill - 2nd shift

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.

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.