Senior Laboratory Manager
4 weeks ago
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.
- 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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