Supervisor, Formulation and Fill

Job Summary

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.
  
  

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
• 3 to 5 years of aseptic processing and aseptic area techniques experience
• Experience with technical writing, root cause analysis and completing investigations, CAPAs, deviations and change controls
  
  

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).