Associate Specialist, Quality Control, Lab Support
Merck
Position Responsibilities / Summary:
- Advanced preparation of maintenance jobs; maintain equipment data, preventive maintenance data, and calibration data.
- Process change control for equipment and preventive maintenance documentation; coordinate calibration program and maintenance planning operations for laboratory consistency.
- Plan and schedule maintenance work orders and preventive maintenance (PMs); maintain equipment histories; analyze equipment & preventive maintenance effectiveness and track maintenance metrics.
- Demonstrate mastery of maintenance management programs (Inventory Control, Calibration Program, Preventive Maintenance Program, SAP, Work Order Control, etc.).
- Maintain positive vendor relations and support review/completion of vendor services; assure compliance with FDA & GMP regulations.
- Influence internal teams and outside vendors to execute corrective maintenance and complete preventative maintenance; recognized resource for maintenance reports, standards, and metrics.
- Provide input to Maintenance and Repair Budgets; implement cost-saving initiatives; conduct process improvement reviews of maintenance planning responsibilities.
Key Functions:
- Initiate/lead problem solving to prevent reoccurrence, reduce downtime, and increase equipment reliability.
- Escalate safety/quality/downtime events; timely approval of qualification, change control, procedures, and documents.
- Provide operational SME support for installation of new equipment and/or modifications.
- Maintain preventive maintenance/calibration programs; attend improvement meetings; liaison with leadership and external vendors.
- Use Root Cause Analysis; author/review/approve quality investigations; participate in audits/inspections; identify equipment trends and corrective actions.
- Create/revise SOPs, forms, and other equipment-related documents.
Minimum Education:
- Bachelor of Science (preferred in Chemistry, Biology, or Engineering).
Required Experience & Skills:
- Pharmaceutical laboratory experience.
- CMMS knowledge (ideally SAP).
- Vendor/contractor management experience.
- Cycle time and inventory management; GMPs; government regulations.
Required Skills (selected):
- Analytical problem solving, auditing, corrective action/maintenance management, data analysis, equipment reliability improvement, GMP compliance, maintenance planning, equipment reliability/inspection, regulatory compliance.
Application:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is listed on the posting.