April 30, 2018
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.
The Quality Control Manager will support clinical operations by ensuring the laboratory reagents and materials meet the high quality and standards of the company.
- 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.
- 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 firstname.lastname@example.org 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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