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 Assurance Manager with experience in a CLIA regulated clinical diagnostic lab to join our growing team.
The Quality Assurance Manager will support clinical operations by ensuring the laboratory meets all regulations for high complexity molecular testing.
- 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.
- 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 email@example.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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