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

• 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