Quality Control Manager

April 30, 2018
Baltimore, Maryland


Overview:

PapGene, Inc. is a Baltimore-based molecular diagnostics company commercializing high-complexity laboratory developed tests (LDTs) for cancer diagnostics. PapGene’s core technology uses innovative massively parallel sequencing (MPS) techniques invented by world-leading cancer researchers at Johns Hopkins University.

PapGene is seeking a Quality Control Manager with experience in a CLIA regulated clinical diagnostic lab to join our growing team.

Essential Duties:

The Quality Control Manager will support clinical operations by ensuring the laboratory reagents and materials meet the high quality and standards of the company.

Specific Responsibilities:

  • Receive, track, label and test reagent for laboratory operations.
  • Monitor the testing and QC of reagents.
  • Preparation of reagents for routine and non-routine testing e.g., aliquoting, lot to lot verification.
  • Develop relationships with vendors, generate purchase orders.
  • Maintain reagent inventory for routine and non-routine analysis. Liaising with all departments following group strategy in reagent purchasing. 
  • Ensure accurate record keeping and document control practices.
  • Monitor production runs for reagent quality by measuring and documenting using statistical process control.
  • Assist with external and state inspections and take corrective actions as necessary.
  • Monitor and ensure compliance to all OSHA requirements.
  • Monitor and ensure quality standards set by the company for all samples being processed.
  • Coordinate with management to resolve any issues regarding reagent quality.
  • Suggest, plan and organize future growth of inventory for laboratory operations.

    Requirements:

    • Minimum of a Bachelor’s degree in biology and/or chemistry or equivalent.
    • Direct or related experience of 3 years with GLP/GCP training.
    • Versed in Six Sigma, 5S, and Problem solving focusing on Continuous Improvement.
    • Analytical ability and problem-solving skills.
    • Working knowledge of fundamental quantitative analysis and statistical methods.
    • Technical writing skills to create policy documents and audit reports.
    • Good knowledge of MS Office and databases.
    • Outstanding communication skills.
    • Great attention to detail and results driven approach.

    To be considered for this position, please forward a copy of your resume to hr@papgeneinc.com and include a cover letter explaining why you think your background is a good fit for this job description.

    © 2017 PapGene, Inc.



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