Senior Laboratory Operations Manager

2 weeks ago

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

Job Overview

Join Millstone Medical and immerse yourself in a dynamic environment where your contributions are valued, and professional growth is encouraged.

Millstone Medical Outsourcing, a rapidly expanding provider of medical services to 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 maintaining the highest quality standards.

In addition to laboratory testing, Millstone engages in mechanical inspection and assembly services tailored to meet the outsourcing needs of medical device manufacturers, ensuring cost efficiency without compromising quality, accuracy, or timeliness. Our rigorous internal quality system guarantees compliance with FDA and ISO standards.

What We Offer:

A commitment to quality, career advancement, and a supportive work environment.

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

Total Rewards Benefits Program Includes:

  • Medical Coverage - Effective from the first day of employment
  • Dental Coverage - Effective from the first day of employment
  • Vision Coverage - Effective from the first day of employment
  • Supplemental Benefits - Life, Disability, Critical Illness
  • Paid Time Off
  • Tuition Reimbursement
  • Career Development Opportunities
  • 401(k) Plan with Employer Match

Key Responsibilities:

  • Oversee and direct a team of quality control microbiology laboratory professionals in a contract testing environment, ensuring adherence to high technical standards and quality protocols. Responsibilities include sample management, testing timelines, equipment upkeep, inventory oversight, and supply procurement.

· Provide mentorship and leadership to team members, promoting a culture of continuous improvement and excellence.

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

· Implement corrective measures in response to audit findings.

  • Establish and uphold procedures for quality control testing, including the creation and review of standard operating procedures (SOPs), protocols, and reports in accordance with ISO 13485/17025 quality management systems.
  • Play a pivotal role in regulatory inspections and preparation activities.
  • Ensure compliance of reports with established procedures, accurately reflecting testing data and outcomes.
  • Act as the final authority for assigned studies, ensuring traceability of samples and data throughout the testing process.
  • Verify that raw data and statistical analyses are accurate and representative of the original data.

Regulatory Compliance:

  • Possess knowledge of relevant regulatory standards (GMP, GLP, ISO, etc.) and company policies.
  • Ensure that testing procedures are approved, communicated, and adhered to by all analysts, with accurate and timely data recording.
  • Document any deviations from established 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 provide testing quotes and maintain awareness of pricing and credit policies.
  • Coordinate workflows to meet client expectations.
  • Stay informed on current technical and scientific advancements.
  • Ensure proper training for analysts, ensuring they are knowledgeable about 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, particularly in a technical management capacity.

Additional Information:

Millstone is an equal opportunity employer, committed to diversity and inclusion in the workplace. 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 employment 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:

  • How many years of experience do you have in a microbiology laboratory focused on pharmaceutical, biotechnology, or medical device products?

Experience Requirements:

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

Relocation Requirement:

  • Willingness to relocate before starting work (Required)

Work Location: In-person

  • Producer Operations Senior Manager

    2 months ago

    West Bloomfield Township, Michigan, United States The Cigna Group Full time

    Role Summary Leads the Producer Licensing & Commissions Operations Teams to ensure timely and accurate payment by means of various compensation channels. Producer Operations includes Producer Licensing & Appointments, Producer Commissions, and Producer Operations Systems Support. This position will have direct oversight of the managers and their teams that...

  • Caregiver - Senior Care Specialist

    3 days ago

    West Bloomfield Township, Michigan, United States Sunrise Senior Living Full time

    About the RoleWe are seeking a compassionate and dedicated Caregiver to join our team at Sunrise Senior Living. As a Caregiver, you will play a vital role in providing exceptional care and services to our residents, ensuring their physical, emotional, and social needs are met.Key ResponsibilitiesBuild meaningful relationships with residents and their...

  • Senior Operations Supervisor

    2 weeks ago

    West Bloomfield Township, Michigan, United States Kamatics Corporation Full time

    Senior Operations SupervisorRequisition IDCategory Operations ManagementSegment Kaman AerospaceShift Shift 1# of Openings 1OverviewWe are seeking a highly skilled and motivated Senior Operations Supervisor to enhance our team dynamics. This role is crucial for overseeing the productivity and quality standards within our operations.Kaman Specialty Bearings &...

  • Senior Operations Supervisor

    2 weeks ago

    West Bloomfield Township, Michigan, United States Kamatics Corporation Full time

    Senior Operations SupervisorRequisition IDCategory Operations ManagementSegment Kaman AerospaceShift Shift 1# of Openings 1OverviewWe are seeking a proactive and skilled Senior Operations Supervisor to oversee our manufacturing processes. This role is essential in ensuring operational excellence within our organization.Kaman Specialty Bearings & Engineered...

  • Senior Operations Supervisor

    2 weeks ago

    West Bloomfield Township, Michigan, United States Kamatics Corporation Full time

    Senior Operations SupervisorRequisition IDCategory Operations ManagementSegment Kaman AerospaceShift Shift 1# of Openings 1OverviewWe are seeking a proactive and skilled Senior Operations Supervisor to oversee our dynamic team. This role is pivotal in ensuring the efficiency and quality of our production processes.Kaman Specialty Bearings & Engineered...

  • Senior Project Management Advisor

    1 month ago

    West Bloomfield Township, Michigan, United States The Cigna Group Full time

    POSITION SUMMARY: This position leads business and operations management activities for one or more teams in the Enterprise Architecture organization and reports to either a Senior Director or Managing Director.As a Senior Advisor focused on ensuring the Enterprise Architecture organization operates effectively, this role will be responsible for various...

  • IT Project Management Senior Advisor

    2 months ago

    West Bloomfield Township, Michigan, United States The Cigna Group Full time

    The job profile for this position is IT Project Management Senior Advisor, which is a Band 4 Senior Contributor Career Track Role.Excited to grow your career?We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see...

  • Clinical Program Senior Manager

    1 month ago

    West Bloomfield Township, Michigan, United States The Cigna Group Full time

    The job profile for this position is Clinical Program Senior Manager, which is a Band 4 Management Career Track Role.Excited to grow your career?We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is right for...

  • Operations Manager

    1 week ago

    West Bloomfield Township, Michigan, United States WEN National Holdings Full time

    Job Summary:As a Shift Manager at WEN National Holdings, you will play a critical role in ensuring the smooth operation of our restaurants. This is an exciting opportunity to join a dynamic team and take on new challenges.Key Responsibilities:Assist in the Execution of Daily Operations: Collaborate with the restaurant management team to execute daily...

  • Logistics Route Manager

    7 days ago

    West Bloomfield Township, Michigan, United States Orchard Laboratories Full time

    Position Overview:Orchard Laboratories is in search of a dedicated Route Coordinator/Courier. This pivotal role involves the formulation and management of daily routes, work assignments, and training schedules for the designated team.Key Responsibilities:1. Develop and oversee the daily operational routes for the courier team.2. Execute various...

  • Logistics Route Manager

    2 weeks ago

    West Bloomfield Township, Michigan, United States Orchard Laboratories Full time

    Position Overview:Orchard Laboratories is in search of a dedicated Route Coordinator/Courier. This position is responsible for the development and coordination of daily routes, work assignments, and training schedules for the assigned team.Key Responsibilities:1. Oversee the daily routing of deliveries and ensure efficient operations.2. Manage administrative...

  • Sales (IC) Senior Advisor

    2 months ago

    West Bloomfield Township, Michigan, United States The Cigna Group Full time

    The job profile for this position is Sales (IC) Senior Advisor, which is a Band 4 Senior Contributor Career Track Role.Excited to grow your career?We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is right...

  • Logistics Route Manager

    7 days ago

    West Bloomfield Township, Michigan, United States Orchard Laboratories Full time

    Position Overview:Orchard Laboratories is looking for a dedicated Route Coordinator/Courier. This role is essential in developing and managing the daily logistics, work assignments, and training schedules for the assigned team.Key Responsibilities:1. Coordinate daily routes and schedules for the courier team.2. Perform various administrative tasks to support...

  • Senior Architecture Advisor

    1 week ago

    West Bloomfield Township, Michigan, United States The Cigna Group Full time

    About the RoleThe Cigna Group is seeking a highly motivated and experienced Senior Architecture Advisor to join our Individual & Family Plans (IFP) IT Team. As a key member of our team, you will play a critical role in delivering value for the business through your deep understanding of the business functions, ability to influence others, and expertise in...

  • Restaurant Operations Manager

    2 days ago

    West Bloomfield Township, Michigan, United States Domino's Franchise Full time

    Job DescriptionAs a key member of the Domino's Franchise team, the General Manager will be responsible for overseeing the daily operations of the store, ensuring that all tasks are completed efficiently and effectively.Key Responsibilities:Manage store staff, providing guidance and training to ensure they are equipped to handle customer inquiries and...

  • Splunk Cribl Senior Engineer

    1 month ago

    West Bloomfield Township, Michigan, United States The Cigna Group Full time

    The job profile for this position is Infrastructure Engineering Senior Advisor, which is a Band 4 Senior Contributor Career Track Role.Excited to grow your career?We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position...

  • Architecture Senior Advisor

    2 months ago

    West Bloomfield Township, Michigan, United States The Cigna Group Full time

    The job profile for this position is Architecture Senior Advisor, which is a Band 4 Senior Contributor Career Track Role.Excited to grow your career?We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is right...

  • Patient Access Operations Manager

    2 weeks ago

    West Bloomfield Township, Michigan, United States Clinical Management Consultants Full time

    Job OverviewClinical Management Consultants is in search of a skilled and committed Patient Access Operations Manager. This pivotal role is essential for enhancing patient access and care coordination within our healthcare facility, ultimately contributing to improved patient experiences and operational efficiency.Our organization is a community-centered,...

  • Information Protection Senior Advisor

    4 weeks ago

    West Bloomfield Township, Michigan, United States The Cigna Group Full time

    The job profile for this position is Information Protection Senior Advisor, which is a Band 4 Senior Contributor Career Track Role.Excited to grow your career?We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you...

  • Regional Facilities Operations Manager

    2 weeks ago

    West Bloomfield Township, Michigan, United States FullSteam Full time

    Job OverviewPosition Title: Regional Maintenance ManagerReports To: National Maintenance DirectorCompensation: $70,000 - $85,000Travel Requirements: Significant travel requiredWe are seeking highly skilled professionals in the fields of Ammonia Refrigeration Systems, HVAC, Fire Sprinkler, and Electrical Systems. Candidates must possess substantial experience...