Lead Microbiology Lab Supervisor

1 week ago

West Bloomfield Township, Michigan, United States Millstone Medical Full time

Job Overview

Join Millstone Medical and be part of a rapidly expanding organization where you can enhance your skills in a supportive and employee-focused environment, witnessing the impact of your contributions.

Millstone Medical Outsourcing, a dynamic and fast-growing provider of medical services for leading orthopedic firms, is seeking talent for its Connecticut division. With over three decades of experience in laboratory testing for medical devices and pharmaceuticals, environmental assessments, and regulatory support, Millstone Testing operates as an ISO 13485:2016 certified contract manufacturer in an FDA-registered facility, committed to the highest quality standards.

In addition to laboratory testing, Millstone engages in mechanical inspection and assembly, catering to the outsourcing needs of medical device manufacturers who aim to reduce costs while ensuring quality, precision, and promptness. Our rigorous internal quality system guarantees compliance with ISO standards.

What We Offer:

A commitment to quality, professional growth, and career development.

At Millstone, we prioritize your well-being both professionally and personally. Alongside competitive salaries, our Total Rewards Benefits Program is designed to support the health and emotional wellness of our employees and their families.

Total Rewards Benefits Program Includes:

  • Medical coverage starting on your first day
  • Dental coverage starting on your first day
  • Vision coverage starting on your first day
  • Supplemental benefits including Life, Disability, and Critical Illness
  • Paid Time Off
  • Tuition Reimbursement
  • Career Development Opportunities
  • 401(k) plan with matching contributions

Key Responsibilities:

  • Oversee and lead a team of quality control microbiology laboratory professionals in a contract testing environment, ensuring technical excellence and compliance with quality standards. Responsibilities include sample management, testing schedules, equipment upkeep, inventory management, and supply procurement.

· Provide mentorship and guidance to team members, fostering a culture of continuous improvement and high performance.

  • Serve as the primary contact and subject matter expert for clients regarding all laboratory testing services.
  • Manage and execute routine quality control testing such as bioburden, endotoxin, growth promotion, microbial identification, and raw materials testing.
  • Develop, validate, and oversee new testing methodologies.

· Implement corrective actions in response to audit findings.

  • Establish and maintain quality control testing procedures, including the writing and reviewing of SOPs, protocols, and reports in accordance with the company's ISO 13485/17025 quality management system.
  • Play a key role in regulatory inspections and preparation.
  • Ensure that reports comply with established procedures and accurately reflect testing data and conclusions.
  • Act as the final authority for assigned studies, ensuring sample and data traceability throughout the testing process.
  • Verify that raw data and calculations accurately represent the findings.

Regulatory Compliance:

  • Possess knowledge of relevant regulatory requirements (GMP, GLP, ISO, etc.) and internal company policies.
  • Ensure test procedures are approved, communicated, and adhered to by analysts, with all data accurately recorded.
  • Document any deviations from test methods and implement corrective actions as necessary.
  • Meet or exceed client expectations, maintaining regular communication regarding testing progress.
  • Collaborate with cross-functional teams, including Quality Assurance and Sales, to support testing quotes and maintain an understanding of pricing and credit policies.
  • Coordinate workflow to meet client expectations.
  • Stay updated with the latest technical and scientific developments.
  • Ensure that analysts receive proper training and comprehend the testing processes.

Qualifications:

  • Bachelor's degree in Microbiology or a related field
  • 4-8 years of experience in an ISO 17025/13485 microbiology laboratory in a managerial capacity.

Additional Information:

Millstone is an equal opportunity employer. We do not discriminate against any applicant or employee based on 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 law.

All job offers are contingent upon successful completion of pre-employment drug screening and background checks, in accordance with applicable laws.

Work Schedule:

  • 8-hour shifts
  • Monday to Friday

Application Inquiry:

  • What is your experience in a microbiology laboratory, particularly in pharmaceutical, biotechnology, or medical device sectors?

Experience Requirements:

  • ISO 13485 environment: 1 year (Required)
  • Quality control laboratory management: 1 year (Required)

Relocation:

  • Willingness to relocate as required.

Work Location: In-person

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