QC Associate – Specifications & Testing

PNP Pharmaceuticals is currently seeking for a QC Associate – Specifications & Testing to join our Quality Control team.

Hours:

  • 9:00am to 5:00pm, Monday to Friday

Principal Duties and Responsibilities:

  • Prepare raw material, packaging material, bulk and finished product specifications following approved monographs, manufacturers specifications, clients and PNP requirements (i.e. either in a paper based or electronic system).
  • Complete raw material and packaging material files for vendor approval process to ensure that raw materials and packaging components meet all regulatory and industry requirements.
  • Follow-up on test results with contract test laboratories in relation to Sample Analysis Requests (SARFs) or any other type of lab submission forms.
  • Review of test results against requirements/specifications as per SARFs/lab submissions forms; gather test results and suppliers’ Certificate of Analysis (C of As) for QC release.
  • Prepare raw material, packaging material, bulk and finished product testing sheets by adding the test results for Quality Managers approval where applicable (i.e. either on a paper-based system or electronic system).
  • Assist in the investigation of OOS results.
  • Prepare reports, such as but not limited to OOS, Deviations and CAPA.
  • Assist in the review of Manufacturing and Packaging Batch Records.
  • Review of invoices from contract test laboratories and provide feedback on test charges.

    Additional Duties and Responsibilities:

    • Perform routine tests such as pH, moisture, gluten, flow, DT, bulk density, etc.
    • Other duties that may be assigned.
    • Offer suggestions for process improvement when identified.
    • Support the QA/QC department, as needed.

Qualifications and Requirements:

  • Science related diploma in a related field as Chemistry, Pharmacy, or Biology.
  • Minimum 1 year of experience in a supervisory role or experience leading a team is an asset.
  • Has practical experience in area of responsibility – Analytical Test Methods (USP, NF, AOAC, EP, etc.) and Instrumentation such as HPLC, ICP, GC, UV, IR, etc.

Knowledge, Skills and Abilities:

  • Minimum 1 to 3 years of experience in related field is preferred.
  • Trained in Good Manufacturing Practices (GMP).
  • Good computer skills: proficient in MS Office.
  • Extreme attention to detail.
  • Ability to work independently and in a team.

If you are interested in this position, please apply send us an email at careers@pnppharma.com with your resume and subject title: “QC Associate – Specifications & Testing”

We thank all applicants in advance for your interest in PNP Pharmaceuticals, but only shortlisted candidates will be contacted for an interview.