Cleanroom Supervisor

Company: Fagron GmbH & CO. KG
Location: Boston
Posted on: October 31, 2024

Job Description:

As the Packaging Supervisor, you will assist pharmacists and room supervisors oversee all required activities for the preparation of materials and manual aseptic filling of compounding sterile products within an ISO 7 environment.

• Successfully pass and remain qualified for entrance into the ISO 7 cleanrooms.
• Successfully pass media fill and remain qualified to assist with tasks within the ISO VLFH as required.
• Must be able to stand and maneuver around the tight spaces of a cleanroom for upwards of 7 hrs. per day.
• Assist in overseeing all ISO 7 cleanroom activities including but not limited to: cleaning of VLFHs, the preparation of materials required to aseptically reconstitute, pool and dilute drug product, manual aseptic filling of drug product, performing calibration checks and environmental plating of operators.
• Must be able to rapidly assess situations, troubleshoot production concerns, guide operators, and effectively communicate complex detailed information to management outside of the cleanrooms via electronic tools frequently and quickly.
• Ensuring compliance to SOPs, batch records and HR policies, assisting in disciplinary action as needed.
• Meet Right First Time (RFT) metrics by reducing error/deviations and completing corrections quickly.
• Review and maintain adherence to the manufacturing schedules.
• Track employee training to ensure compliance.
• Aid in bi-annual reviews of procedures.
• Provide on-the-floor leadership to the production team.
• Assist in coaching and training of technicians in the manufacturing suites.
• Support process improvements and scale up initiatives within the department.
• Approve electronic timekeeping for reports.
• Manage personnel to operational standards and complete performance evaluations.Minimum Requirements:
  • 7 years of experience working in a regulated environment with a minimum of 3 to 5 years' experience in a leadership position (i.e., Shift of Line Leader, Group Leader, etc.) or demonstrated leadership abilities.
  • Good working knowledge of all functional areas of the inspection and packaging area.
  • Solid math and effective problem-solving skills with demonstrated use of sound judgment.
  • Good communication and organizational skills, strong interpersonal skills.
  • Demonstrated ability to work effectively and lead a team.We believe in our people and foster a supportive environment that develops and rewards performance and incentivizes long-term career success. Our benefits include, but are not limited to:
    • Health, Vision, and Dental Insurance
    • Company Paid Life Insurance
    • Generous Paid Holidays
    • Generous Paid Time Off and Rollover
    • Company matching 401K and Retirement Savings Plans
    • Employee Assistance Program
    • Flexible working arrangements
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Keywords: Fagron GmbH & CO. KG, Lowell , Cleanroom Supervisor, Other , Boston, Massachusetts