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.
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 LabClean room/controlled classified areas Manufacturing/production areas OfficeExposure 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 experience6 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
  • ExperienceMinimum 2 – 5 years of supervisory or team lead experience5 to 7 years of aseptic processing and aseptic area techniques experience

Also on the board Same function, level within a rung

Level

Senior

Location

Billerica, MA

Occupation

First-Line Supervisors of Production and Operating Workers

Industry

Pharmaceutical Preparation Manufacturing

Posted

yesterday

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