Facilities Associate- Inspection Readiness Lead onsite

The Lab Facility Coordinator is responsible for overseeing and managing the maintenance activities of building and equipment. This role includes scheduling and planning repairs, managing records through the Blue Mountain Regulatory Asset Management system, overseeing spare parts inventory, and processing Deviations, Change Controls, and CAPAs within the Facilities department. Responsibilities

• Coordinate and schedule preventive maintenance, corrective maintenance, and calibration activities with vendors and equipment/area owners in a dynamic manufacturing environment. Ensure proactive and regular communication of schedule and status with stakeholders, including rescheduling on short notice to minimize impact to GMP manufacturing and testing laboratory operations.
• Act as the CMMS Facilities business owner, including creating and processing CMMS work instructions, maintenance and calibration templates, asset records, and associated documentation. Ensure timely creation, completion, and approval of CMMS records according to governing SOPs and Work Instructions.
• Ensure Facilities documents and records are completed in a timely manner and in accordance with GMP practices. Organize and clearly document maintenance records, including filing original documents.
• Assist with the tracking, processing, and renewal of maintenance service agreements prior to expiration dates. Update service agreement tracker, maintain service agreement files, and forward approved POs to the vendor.
• Assist with the development, processing, and submission of Quality System documentation, including SOPs, Deviations, CAPAs, and Change Controls.
• Perform all activities in compliance with applicable cGMP standards., Dashboard Scheduling Operations Leadership Management Checklists Investments Housekeeping Coordinating

Planning Visionary Scheduling Innovation Cleanrooms Calibration Communication Investigation Change Control Asset Management Root Cause Analysis Equipment Maintenance Preventive Maintenance Corrective Maintenance Artificial Intelligence Inventory Control Systems Quality Management Systems Engineering Design Process Good Manufacturing Practices Corrective And Preventive Action (CAPA) Computerized Maintenance Management Systems, * BS/BA or equivalent post-secondary education in a technical or scientific field

• 3+ years of experience or familiarity with GMP clean room equipment maintenance and calibration practices and terminology
• Experience authoring and/or processing Deviations, CAPAs, and Change Controls in a GMP environment, including use of root-cause analysis or other investigation techniques
• Experience with Computerized Maintenance Management Systems, ideally Blue Mountain Regulatory Asset Management system

Work Environment

The work environment includes lab, clean room, and manufacturing settings. Job Type & Location, Communication Risk Analysis Accountability Report Writing Subcontracting Follow Through Safety Training Detail Oriented Microsoft Excel Problem Solving Reporting Tools Site Inspection Team Leadership Microsoft Office Business Metrics Field Inspection Operational Risk Critical Thinking Preventive Action Lean Manufacturing Influencing Skills Performance Metric Kaizen Methodology Process Improvement Project Coordination Microsoft PowerPoint Organizational Skills Packaging And Labeling Commercial Real Estate Verbal Communication Skills Environment Health And Safety Continuous Improvement Process Facility Repair And Maintenance, Philadelphia, PA*On-Site

Filing Planning Visionary Scheduling Innovation Cleanrooms Calibration Communication Investigation Change Control Asset Management Root Cause Analysis Equipment Maintenance Preventive Maintenance Corrective Maintenance Artificial Intelligence Inventory Control Systems Quality Management Systems Engineering Design Process Good Manufacturing Practices Corrective And Preventive Action (CAPA) Computerized Maintenance Management Systems

This is a Contract position based out of Philadelphia, PA. Pay and Benefits

The pay range for this position is $43.27 - $48.08/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type

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