About this role
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