Quality Assurance 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 Assurance Manager with experience in a CLIA regulated clinical diagnostic lab to join our growing team.

Essential Duties:

The Quality Assurance Manager will support clinical operations by ensuring the laboratory meets all regulations for high complexity molecular testing.

Specific Responsibilities:

  • Devising procedures to inspect and report quality assurance issues.
  • Monitoring all operations that affect quality.
  • Supervising and guiding inspectors, technicians and other staff.
  • Assure the reliability and consistency of production by checking processes and final output.
  • Appraise customers’ requirements and make sure they are satisfied.
  • Report all malfunctions to production executives to ensure immediate action.
  • Facilitate proactive solutions by collecting and analyzing quality data.
  • Review current standards and policies.
  • Keep records of quality reports, statistical reviews and relevant documentation.
  • Ensure all legal standards are met.
  • Communicate with external quality assurance officers during on-site inspections.
  • Management of the CAPA process.
  • Preparation of applications for new licensures and scheduling site visits.
  • Responsible for scheduling and reporting for the laboratory PT program.
  • Perform vendor assessments.
  • Responsible for the preparation and hosting of audits and follow up with responses and corrective actions to findings.
  • Review and maintain compliance for all SOPs.

    Requirements:

    • BSc/BA with Certification of quality control is a strong advantage (ISO 9000, Six Sigma etc.).
    • Strong customer service orientation with a proven ability to build and cultivate positive client relations.
    • Proven experience as a quality assurance manager or relevant role in a CLIA laboratory preferred.
    • Thorough knowledge of methodologies of quality assurance and standards.
    • Excellent numerical skills and understanding of data analysis/statistical methods.
    • Good knowledge of MS Office and databases.
    • Outstanding communication skills.
    • Great attention to detail and results driven approach.
    • Excellent organizational and leadership abilities.

    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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