Senior Metrologist, Quality Control

Company: Akorn, Inc
Location: Somerset
Posted on: April 10, 2021

Job Description:

SUMMARY:The Quality Control Senior Metrologist manages all activities associate with QC Analytical instruments such as HPLC, UPLC, GC qualification, maintenance, calibration and documentation. Will perform preventative maintenance of HPLC, UPLC and GC systems, etc. in accordance with company practices. Will coordinate with the QC Chemistry Group and external vendors to ensure laboratory instrumentation are properly calibrated and on-schedule to comply with regulatory guidelines. Must perform all work independently with minimal supervision. ESSENTIAL FUNCTIONS:Include the following.

• Support Instrument Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ) and repair qualification as applicable per current procedures.
• Maintain, schedule and Conduct Preventative Maintenance (PM) and periodic calibration of Laboratory Instruments and also maintain the list of required parts to support routine repair and PM.
• Perform and document qualifications on laboratory instrumentation (i.e. HPLC, GC, KF, UV-Vis, FTIR, etc.)
• Troubleshoot instrumentation problem and work with approved vendors or Instrument manufacturers to bring resolution. Perform urgent/priority repairs including user accessible consumables (i.e. lamps, pumps, seals, tubing, etc.)
  • Author and/or review instrument related technical documents (like SOPs, Qualification Protocols, change controls etc.) and assist in making those effective by collaborating with other departments.
  • Manage laboratory instrument vendor relationships, including scheduling and emergency repairs
  • Review all calibration documentation for thoroughness and accuracy, in alignment with Akorn procedures and applicable current requirements in timely manner.
  • Develop and/or revise calibration procedures and standard operating procedures, Qualification protocols etc. and route those to make those effective by collaborating with other departments. Provide or schedule training through vendor to the QC Chemists as necessary.
  • Effective verbal and written communication with team members and other departments of the organization.
  • Ability to write effective out-of-specification (OOS) and out-of-trend (OOT) investigation reports related to instrument calibration/qualification issues.
  • Basic IT understanding of chromatographic software and administrative roles for software; comprehension of data storage and back-up.ADDITIONAL RESPONSIBILITIES:
    • Maintain lab equipment in good working order.
    • Work on the bench to perform sample analysis as required.
      • Lead, train, mentor, coach and/or supervise other Chemists or Metrologists as needed.
      • Other duties as assigned or required.

Keywords: Akorn, Inc, Trenton , Senior Metrologist, Quality Control, Other , Somerset, New Jersey