• Akorn
  • Flemington , NJ
  • Non-Executive Management
  • Full-Time
  • 18 Brentwood Ct

Include the following. Other duties may be assigned.

  • Schedules production activities with the Director of Operations, according to sales orders.
  • Conducts new production employee training according to current Standard Operation Procedures (SOP s) and General Manufacturing Procedures (GMP) requirements.
  • Manages the following departments: Pharmacy, Compounding, Aseptic Filling, Packaging, Autoclaving and Cleaning Sanitization.
  • Reviews filling and compounding operations to verify conformance with established specifications.
  • Coordinates and manages the re-certification of aseptic manufacturing via media fills and smoke studies.
  • Perform (in conjunction with the QA department) investigations within the manufacturing department. Must have an understanding of the Trackwise investigation system
  • Develops departmental Standard Operating Procedures.
  • Co-chair employee action committee.
  • Assist in annual budgeting process and monthly department variance analysis.
  • Must pass the gown certification process.
  • Audits daily sterilization records, sanitization records and equipment log books.
  • Performs production department intermediate and final batch record audits when required.
  • Evaluation and purchase of production supplies and suppliers.
  • Manage manufacturing personnel required to support aseptic filling and compounding activities during assigned shift.
  • Interviewing, hiring, training, reviewing, and issuing disciplinary action, as necessary, for all manufacturing personnel.
  • Interaction with Regulatory Agencies (FDA, DEA, OSHA) and contract clients.
  • Qualifications

    Bachelor of Science degree and a minimum of five+ years related experience in an aseptic pharmaceutical environment is required. Must have experience managing employees. Extensive experience in aseptic behaviors and techniques is a must.

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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