Lab Manager PC 990

Miltenyi Biomedicine • Gaithersburg, MD

12d • $68,919 - $81,099 • Onsite

About The Position

This position is responsible for managing and coordinating the operation,
maintenance, and lifecycle of Quality Control (QC) laboratory equipment and
systems in a cGMP environment. The role ensures that QC equipment, computerized
systems, and laboratory infrastructure remain compliant, operational, and
properly maintained through coordination with internal departments and external
vendors. The position supports laboratory operations through equipment
oversight, inventory management, system administration, and compliance with
regulatory requirements including 21 CFR Part 11.

Requirements

• Bachelor’s (B.S.) degree from a four-year college or university; +3 years of experience working in a cGMP laboratory and performing hands on work in a Quality Assurance/Quality Control setting.
• Strong organizational skills and attention to detail are required.
• Excellent written and oral communication skills and must be able to interact with a cross-functional team-members.
• Strong skills with Microsoft Office applications (Excel, Office, PowerPoint, Outlook, etc.)

Nice To Haves

• The ideal candidate will have experience with purchasing and commissioning QC laboratory equipment and analytical systems.
• Experience fulfilling material needs and supplies for a laboratory strongly desired.
• Experience with SAP strongly desired.

Responsibilities

• Responsible for the management of all QC lab equipment, ensuring that all QC equipment is properly maintained and calibrated on schedule, and that all calibrations and preventive maintenance certificates are uploaded into the current document management system.
• Manage Quality Control on-call team for equipment support (training, scheduling & coordination).
• Train & support QC lab technician(s).
• Serve as the primary liaison to Facilities and Validations departments; generate the necessary forms (e.g., induction forms, IQ/OQ/PQ) for all new equipment and work orders for existing equipment servicing.
• Serve as the primary QC liaison to Procurement department; manage and coordinate equipment quotes and purchase orders, service agreements, calibrations, maintenance, repairs, and service entries.
• Serve as the primary QC liaison to outside service vendors; escort vendors onsite and ensuring proper documentation is completed for external servicing.
• Support 21 CFR part 11 compliance and work with QA to ensure structure for equipment maintenance is set up and maintained. Communicate and enforce that structure across the various QC functions.
• Develop and maintain inventory of QC materials and lab supplies, including monitoring, ordering through SAP, and restocking. Order non-routine materials, as needed.
• Serve as the administrator for all QC systems; add and remove users, reset passwords, and pull audit trails as necessary.
• Collaborate with the Data Integrity and Validation departments to ensure that all proposed new equipment and systems are compliant with 21 CFR Part 11 and are fit for purpose.
• Troubleshoot equipment issue with outside vendors and IT department to keep equipment running efficiently.
• Coordinate service with IT department for all equipment and lab computers; assist with equipment installs and new computer installs.
• Assist Validation team with running requalification protocols on QC equipment.
• Initiate and support change controls, deviations, CAPAs, and investigations related to QC equipment and systems.

Benefits

• In addition to your salary, the Company offers a comprehensive benefits package including health, vision, and dental insurance, plus a 401(k) plan.
• All benefits are subject to eligibility requirements.
• Certain positions are eligible for additional forms of compensation such as bonuses or commissions.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 501-1,000 employees