Senior Laboratory Manager

13 hours ago

Bloomfield, Connecticut, United States Millstone Medical Full time
Job Description

Millstone Medical is seeking a highly skilled Sr. Lab Manager to lead our microbiology laboratory team. As a key member of our quality control team, you will be responsible for ensuring the highest level of technical expertise and adherence to quality standards.

Responsibilities:

  • Lead and manage a team of QC microbiology laboratory professionals, ensuring a high level of technical expertise and adherence to quality standards.
  • Provide guidance and mentorship to staff, fostering a culture of continuous improvement and excellence.
  • Act as the primary point of contact and subject matter expert (SME) for customers for all testing services on behalf of the laboratory.
  • Management and performance of routine QC testing, including bioburden, endotoxin, B&F testing, growth promotion, Gram stain, microbial ID analysis, preservative efficacy testing, and raw materials testing.
  • Writing, executing, and overseeing validation of new test methods.
  • Implement corrective actions in response to non-conformities from audits.
  • Establishing and maintaining procedures for QC testing, including writing/reviewing SOPs, protocols, and reports as necessary as per company's ISO 13485/17025 QMS.
  • Play a leading role in regulatory inspections and the preparation for regulatory inspections.
  • Ensure reports are compliant with current procedures and that the final reports accurately reflect the data, results, and conclusions of the testing.
  • Act as a final signature for assigned studies and ensure sample and data traceability are maintained throughout testing.
  • Ensure accuracy of raw data, calculations, and statistics accurately reflect the raw data.

Requirements:

  • B.S. degree in Microbiology or equivalent.
  • 4-8 years ISO 17025/13485 Microbiology laboratory experience in a technical management role.

Additional Information:

Millstone Medical provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status, or any other status protected by applicable federal, state, or local law.

All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.

Schedule:

  • 8 hour shift.
  • Monday to Friday.

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