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Supervisor I, Quality Control - Akorn, Inc. (Westwood)

  • Akorn
  • 415 Old Tappan Rd
  • Westwood, NJ 07675
  • Full-Time

The Supervisor, Quality Control will supervise the chemists and manage all aspects of quality team. Strategically manages the day to day lab operation to assure testing timelines are met.


  • Schedules testing of raw materials, in-process materials, finished products and stability samples.
  • Manage Quality Control team and compliance activities to achieve key site and corporate
  • objectives.
  • Develops testing schedule for raw materials based on the production requirements, finished
  • products for marketing needs and stability samples to provide annual reports.
  • Identifies areas in need of method modification and staff training.
  • Acts as advisor to team members to meet schedules and resolve instrument problems.
  • Ability to successfully work on cross-functional basis with other site supervisors.
  • Maintains knowledge of current trends in Quality Control testing procedures by updating to
  • current USP and vendors testing methodologies.
  • Write and revise SOPs as required.
  • Familiarity with writing product transfer and USP/vendors method verification protocols and
  • reports.
  • Ability to write effective out-of-specification (OOS) investigation and out-of-trend (OOT)
  • reports.
  • Maintain lab equipment in good working order and calibration plan is followed.
  • Assure stability testing plan is maintained and provide data for annual reports for commercial
  • products.
  • Prepare laboratory for customer and FDA audits
  • Assure proper reagents, solvents and other lab supply is maintained in the lab.
  • Obtain quotations for lab equipment and contract testing.
  • Work on the bench to perform sample analysis as required.
  • Other duties as assigned or required.
  • Qualifications

    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


  • Excellent interpersonal, oral, and written communication skills.
  • Requires exceptional attention to detail with the ability to focus on current assignments.
  • While Laboratory mistakes are unavoidable they must be kept to a minimum due to their ramifications.
  • Requires initiative and self-motivation with moderate supervision in a detail-oriented manner.
  • Requires the ability to work on multiple projects in a concurrent manner.
  • Must possess the ability to work in an independent manner, as well as a group environment.
  • Responsible for maintaining confidentiality of work assignments
  • Works in a fast paced, moderately stressful environment. Adherence to project deadlines is critical
  • Proficient with computer programs desirable; or an aptitude to learn computer programs as needed.
  • Proficient with the operation of instrumentation such as HPLC, UV, GC, KF, AA and FTIR
  • Resourceful and well organized.
  • Advanced trouble-shooting skills with the ability to recognize methodology deficiencies
  • Must be able to perform equipment troubleshooting and communicate with equipment manufacturer.
  • Requires comprehensive knowledge of raw materials/products chemical analysis and operation of laboratory instruments.
  • Familiarity with GLP/GMP guidelines.
  • Experience with USP/EP monographs.
  • Ability to meet attendance standards. All full-time employees are required to work a 40-hr week. At times it may be necessary to work additional hours in order to get the required tasks accomplished to meet deadlines.

  • BA or BS in chemistry
  • Minimum 10 years of lab experience performing chemistry related duties and
  • Minimum 3 years of supervisory experience in the pharmaceutical industry.
  • Thorough knowledge of High Pressure Liquid Chromatography (HPLC), Gas Chromatograph (GC), Infra-Red (IR) Spectrophotometer, Ultra Violet/Visible (UV/VIS) Spectrophotometer, Particle Size Analysis, KF Titration and wet chemistry skills are required.

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