Lab Manager *PC 990

Your Role:

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.

Essential Duties and 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.

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.
• 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.
• 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.)

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands or finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a sanitized laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes and computers. While performing the duties of this job, the employee is frequently exposed to blood, viruses (e.g., HIV-1), bacteria, body fluids and other tissues which may be infectious and have the potential to cause disease. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment such as scrubs, coveralls, masks, face shield, glasses and gloves. The noise level in the work environment is usually moderate.

The anticipated base salary range has been established at $68,919 - $81,099/per year. The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialization, skills, abilities, and training. The above salary range represents the Company's good faith and reasonable estimate of the range of possible compensation at the time of posting. 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.

Miltenyi Biotec, Inc is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity

Miltenyi Biotec, Inc. participates in E-Verify.

Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact - one breakthrough at a time. One integral division of that Miltenyi Biotec family is Miltenyi Bioindustry - our contract development and manufacturing organization (CDMO). As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products. This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale. Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.