QC Metrologist


Job ID 19-00071

Industry Computer/IT

Job Type Permanent

Location Dayton, Nj

Description

QC Meteorologist with experience in handling HPLC, GC, Dissolution instruments calibration and PM.



Qualifications

REQUIREMENTS:

  • High school Diploma/Engineering Diploma with 5+ years of experience (pharmaceuticals or related) or BS in Science, engineering or related field with 3 to 5+ years of experience (pharmaceuticals or related)
  • 5+ years of metrology experience in a FDA regulated work environment is preferred
  • Expert in laboratory instrument/equipment qualification, including IQ/OQ/PQs
  • Experience with analytical instruments is preferable
  • Experience in a cGMP environment is required
  • Knowledge and use of Good Documentation practices is required
  • Ability to learn quickly and make sound, scientifically driven decisions that adhere to regulatory practices is required.
  • Coordinate equipment qualification and calibration.
    • During inspection audits provide required expertise, as required.
    • Perform other duties as assigned.
  • Maintain laboratory instruments/equipment documentation.
    • Author of cGMP documents pertaining to instrumentation.
    • Troubleshoot equipment problem and work with instrument manufacturer to resolve issues.
  • Own quality investigation and calibration documentation.
    • Perform instrument/equipment qualification activities.
    • Perform preventive maintenance, calibration, troubleshoot and repair of laboratory instruments and equipment.
  • Will support the quality control laboratory metrology needs.
    • Select and order laboratory instrument/equipment components, parts, tools and standards.

Through knowledge in handling of instruments (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, KF Autotitrator, Bulk Density, and other routine QC instruments) which are using as per as per USP monograph / In-house / any other Compendial monographs.

Independently plan and make adequate inventory of required spare parts. Maintain the PM and Calibration schedules.

Independently plan and execute the activities and keep the systems with less down time.

Prepare and/or Review the SOPs, and Protocols as assigned.

Perform maintenance/minor repairs and calibrations on laboratory instruments/equipment's.

Perform troubleshooting and investigations under the direction of a supervisor.

Comply with all regulatory/in-house requirements (may include but not limited to safety, house keeping, cGMP, cGLP, documentation) when performing the assigned activity.