Senior Laboratory Manager

4 weeks ago


Bloomfield Hills, Michigan, United States Practical Applications Full time
Job Description

Millstone Medical Testing is seeking a highly skilled and experienced Senior Laboratory Manager to lead our microbiology laboratory operations. As a key member of our team, you will be responsible for ensuring the highest quality standards in our laboratory, while also providing guidance and mentorship to our staff.

Key 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.
  • Management/planning of water sampling and associated water testing, including USP test for heavy metals, nitrates, pH, conductivity, etc.
  • Management/planning of environmental monitoring sampling to coincide with testing and manufacturing activities.
  • Implement correct actions in response to environmental monitoring excursions.
  • Establishing and maintaining procedures for QC testing, including writing/reviewing SOPs, protocols, and reports as necessary as per company's ISO 13485 QMS.
  • Review and complete documentation in accordance with current Good Manufacturing Practices (cGMP).
  • Ensure all analytical and microbiological methods are appropriately qualified/validated.
  • Ensure the QC group meets set KPIs and develops a program of continuous improvement.
  • 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 Biology or equivalent.
  • 5-10 years ISO 17025/13485 Microbiology laboratory experience in a technical management role.
  • Extensive experience in a microbiology laboratory, with a focus on pharmaceutical, biotechnology, or medical device products.
  • Knowledge of laboratory testing, equipment, procedures, and basic math sufficient to direct and oversee assigned testing.
  • Previous experience in a leadership or managerial role within a QC laboratory.
  • Ability to follow written procedures.
  • Good documentation practice (GDP).
  • Effective critical thinking, problem-solving, and decision-making skills.
  • Ability to learn and comprehend difficult tasks.
  • Ability to troubleshoot problems.
  • Attention to detail.
  • Effective computer skills: Microsoft Office and laboratory systems.
  • Professional communication skills: verbal, written, and active listening.
  • Ability to organize and manage workload.
  • Ability to meet deadlines.


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