See Link Below to Apply

https://jobs.labcorp.com/

License/Certification/Education: Normally a B.A./B.S. in Biology w/4-5 years of Clinical Laboratory experience.

Internal Description :

Additional language for the Regional Quality Manager for LabCorp Diagnostics

This position collaborates with functional groups to ensure compliance to regulatory and accreditation requirements and provides support for a variety of projects and corporate initiatives. This site is an FDA registered facility that supports the Vantera Clinical Analyzer product line. In addition, the laboratory maintains a CLIA certificate and New York state permit to support clinical trial testing.

Functional responsibilities include

  1. Review technical documents, material specifications, manufacturing validations, etc in support of new products for the Vantera Clinical Analyzer.
  2. Manage and provide Quality review for change request proposals.
  3. Perform incoming product review and release.
  4. Manage the corrective/preventive action program to include post implementation effectiveness.
  5. Oversees the internal audit program and participates as an auditor.
  6. Responsible for continued effectiveness of the external audit program including review of findings and responses to agencies.
  7. Perform external supplier audits
  8. Interface with regulatory and accreditation agencies and ensures the laboratory maintains as current its federal, state, and local licenses and accreditations.
  9. Keeps abreast of new or revised applicable national, state, and local requirements for licensing, certifying, and accrediting agencies. Communicates information clearly, succinctly, and in a timely manner.

Required:

  • B.S. degree in Biology, Chemistry or related field
  • Minimum of 3 years of experience in IVD or medical device industry
  • Minimum of 5-7 years of experience managing Quality Systems
  • Professional knowledge of quality management systems to include the FDA quality system regulations and ISO 13485
  • Must possess excellent leadership, organizational and time management, problem solving, written and verbal communication skills

External Description :

Additional language for the Regional Quality Manager for LabCorp Diagnostics

This position collaborates with functional groups to ensure compliance to regulatory and accreditation requirements and provides support for a variety of projects and corporate initiatives. This site is an FDA registered facility that supports the Vantera Clinical Analyzer product line. In addition, the laboratory maintains a CLIA certificate and New York state permit to support clinical trial testing.

Functional responsibilities include

  1. Review technical documents, material specifications, manufacturing validations, etc in support of new products for the Vantera Clinical Analyzer.
  2. Manage and provide Quality review for change request proposals.
  3. Perform incoming product review and release.
  4. Manage the corrective/preventive action program to include post implementation effectiveness.
  5. Oversees the internal audit program and participates as an auditor.
  6. Responsible for continued effectiveness of the external audit program including review of findings and responses to agencies.
  7. Perform external supplier audits
  8. Interface with regulatory and accreditation agencies and ensures the laboratory maintains as current its federal, state, and local licenses and accreditations.
  9. Keeps abreast of new or revised applicable national, state, and local requirements for licensing, certifying, and accrediting agencies. Communicates information clearly, succinctly, and in a timely manner.

Required:

  • B.S. degree in Biology, Chemistry or related field
  • Minimum of 3 years of experience in IVD or medical device industry
  • Minimum of 5-7 years of experience managing Quality Systems
  • Professional knowledge of quality management systems to include the FDA quality system regulations and ISO 13485
  • Must possess excellent leadership, organizational and time management, problem solving, written and verbal communication skills