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Aseptic Supervisor

5 months ago

Hunt Valley, United States Medix™ Full time

Aseptic Supervisor


Location: Hunt Valley, MD

Shifts: M-F, 1st (7AM to 4PM) and 2nd (3PM to 12AM) Available

Pay: $100K - $125K annually, based on experience


Qualifications:

  • Thorough understanding of cGMP, FDA guidelines, and multinational regulatory standards.
  • At least 2 years of prior management/leadership experience.
  • Minimum of 4 years Aseptic Production experience.
  • Prior experience with regulatory authorities preferred.
  • Bachelor’s degree in Life Sciences or related field, or equivalent work experience.


Responsibilities:

  • Provide leadership to Aseptic Manufacturing Associates of various levels, including hiring, managing, motivating, coaching, and mentoring.
  • Ensure oversight of Aseptic Manufacturing operations across shifts, including weekend support as needed.
  • Complete internal batch record review and assist with authoring and implementing manufacturing procedures and batch records.
  • Lead routine manufacturing activities, including day-to-day scheduling and management of raw materials/consumables.
  • Perform component and equipment preparation, bulk drug formulation, and aseptic filling duties while accurately documenting data and completing batch records.
  • Successfully complete facility’s gowning and media fill qualification program.
  • Train other employees in various manufacturing tasks, including Component Preparation, Formulation Operations, Lyophilization Processes, Product Accountability, and Sterile Filling.
  • Operate and assist with the maintenance of production equipment, performing duties in cleanroom areas and helping to maintain cleanliness.
  • Ensure personnel on shift are trained on all applicable procedures and master batch records prior to execution.
  • Initiate revisions to cGMP procedures and master batch records, and assist in scheduling and performing routine maintenance and calibration of production equipment.
  • Participate in client communications, problem-solving, schedule development, and project status updates.
  • Interface with auditors, including client representatives and regulatory agencies.
  • Perform Manufacturing review and approval of cGMP documentation in support of continuous improvements.
  • Support Agency, customer, and vendor audits as needed while exhibiting professional behavior.
  • Perform all other tasks, projects, and duties as assigned.