Pharmaceutical Operations Manager

4 days ago


Billerica, Massachusetts, United States Wimmer Solutions Full time

Job Summary

As a key member of Wimmer Solutions, the Pharmaceutical Operations Manager will oversee the visual inspection, labeling, and packaging of parenteral pharmaceuticals and dermatological products. This role requires strong leadership skills, with a focus on ensuring quality and efficiency in the manufacturing process.

Key Responsibilities

  • Directly oversee shift leads and floor personnel to improve safety, optimize quality, and elevate performance.
  • Manage all kit inspection, packaging, and labeling operations in accordance with direction from the Operations Director and commercial forecast.
  • Plan, lead, manage, prioritize, and organize work in the ILP and warehouse operations teams.
  • Work cohesively with the Sr. Production manager to ensure packaging area scheduling aligns with production goals.
  • Assign daily duties to groups to accomplish production goals, utilizing personnel effectively.
  • Ensure all staff training and qualifications for Visual Inspection are up to date.
  • Resolve routine to complex inspection and packaging issues and/or equipment problems with staff and/or other departments in a timely fashion.
  • Revise batch records and standard operating procedures (SOPs) as needed to improve efficiency and quality of manufacturing/packaging process.
  • Use systems like SAP, Track-Wise, EDMS, and Master Control, etc.
  • Initiate/Author and complete Deviations, Change Control, CAPAs, etc.
  • Update computer data for packaging department to record production inventory, results, dates, problems, etc.
  • Review all in-process documentation for accuracy.
  • Ensure proper operation of Inspection/Labeling/Packaging equipment.
  • Plan and order supplies for production to assure timely completion of production goals.
  • Make recommendations on efficiency and cost as appropriate.
  • Work under minimal direct supervision, utilizing some standard procedures along with own judgment.
  • Prioritize safety and maintain good housekeeping in the ILP working area and warehouse.
  • Oversee all phases of the Change Control process for owned changes.
  • Hire, train, manage, and motivate staff to meet production and warehouse demands.

Work Conditions:

  • Office
  • Shop/Shipping area
  • Controlled/Manufacturing area

Physical Requirements:

  • Stand, sit, walk, use hands and fingers to handle or feel, reach with hands and arms
  • Climb or balance, stoop, kneel, crouch or crawl, talk or hear, taste or smell
  • Close, color, and peripheral vision, depth perception, ability to adjust focus
  • Correctable 20/20 vision
  • Ability to visually inspect small products and print
  • Be able to multitask
  • Operate label application machinery, thermal transfer printer, computer, serialization, and heat sealing equipment
  • Operate computer/office machines
  • Proper gowning, Safety shoes, safety glasses, gloves
  • Lift up to 30 lbs.

Travel Estimate

Up to 5%

Education and Job Qualification

  • B.S. required
  • Must possess current, valid class D Driver's license
  • Ability to operate and maintain all process equipment
  • Familiarity with FDA cGMP, SOPs, and ISO standards
  • Knowledge of pharmaceutical labeling/packaging equipment and warehouse operations

Experience

  • Minimum 8-10 years related experience with minimum 4-6 years in a supervisory and/or managerial role required
  • Direct experience with manual visual inspection for small volume parenteral required
  • Strong computer skills


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