Senior Laboratory Manager

Come join Millstone Medical Testing and become part of a high growth company where you will have the opportunity to learn and grow in an employee-centric culture and see the importance of your work!

Millstone Medical Outsourcing, a fast growing, fast paced medical service provider for the top Orthopedic companies in the industry is recruiting at its Testing division location in Bloomfield, CT. Millstone Medical Testing (formerly known as MycoScience) has over 30 years of expertise in medical device and pharmaceutical laboratory testing, environmental testing, and related regulatory support services. Millstone is an ISO 13485:2016 certified contract manufacturing organization operating out of an FDA-registered facility with a rigorous approach to quality that upholds Millstone’s commitment to operating under the highest quality standards.

Millstone also engages in other activities, such as mechanical inspection and assembly, which are designed to meet the outsourcing requirements of medical device manufacturers seeking to reduce costs while maintaining high levels of quality, accuracy, and timeliness. We are FDA and ISO registered and employ a detailed internal quality system to ensure ISO compliance.

What's in it for you?

A company committed to quality, growth, career pathing.

At Millstone, we want you to be your best at work and at home. In addition to competitive compensation, we have designed our Total Rewards Benefits Program to support the physical and emotional well-being of our employees and their families.

Total Rewards Benefits Program:

• Medical - Starting on the 1st day of employment
• Dental - Starting on the 1st day of employment
• Vision - Starting on the 1st day of employment
• Supplemental Benefits - Life, Disability, Critical Illness
• Paid Time Off
• Tuition Reimbursement
• Career Pathing
• 401(k) with match

Job description

The Senior Manager has overall responsibility for leading and managing the technical conduct of all assigned tests as well as for the review, interpretation, analysis, documentation, and reporting of results. The Senior Manager is the single point of study control. The Senior Manager ensures compliance with regulatory requirements, overseeing the microbiology laboratory operations, and maintaining high-quality standards .

 

Responsibilities:

• Lead and manage a team of QC microbiology laboratory professionals for a contract testing laboratory, ensuring a high level of technical expertise and adherence to quality standard. Areas include sample management, testing schedules, identification and isolation of detected microbes, equipment maintenance and calibration, inventory control and supply orders.

• 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 such as 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 (basic chemical analysis to include 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.

Regulatory Compliance

• Knowledge of applicable regulatory requirements (GMP, GLP, ISO, etc.) including technical company policies and procedures.
• Ensure tha