Posted to MedZilla on 1/18/2018


Randstad Pharma

Administrative Assistant 20225-MZ


 
 

Job Title: Facilities Scheduling Coordinator

Position Description

  • The position is responsible for providing a wide range of critical support for Facilities Services in the Maintenance Business Office (MBO). The focus of the position will be coordination, planning, scheduling and communication of non GxP and GxP work orders across multiple buildings and campuses. Failure to efficiently evaluate the scope of work required by this position would have serious negative impact on compliance, equipment reliability, and manufacturing up-time.

Position Responsibilities

  • Assign maintenance and calibration work orders generated on a monthly basis. Assign other work orders as needed to support proper work order flow including movement to and from parts, execution, and compliance staff.
  • Assist with scheduling equipment time with MFG for all impacting utility or process PMs, calibrations and repairs (coordinating with Manufacturing Planners).
  • Monitor and manage scheduling and planning inboxes in CMMS.
  • Participation in daily manufacturing planning meeting to determine equipment availability for impacting and non-impacting work.
  • Issue new work orders to follow up on ongoing issues, PM follow-up, or at the direction of supervision/compliance.
  • Assist with reviewing work order requests for appropriate details and scope as part of the pre-execution review process. Work with CMMS users , FAC compliance, and execution staff to clarify work order scope as needed
  • Communicate controlled environment impacting work with Facility Compliance as needed for PMS, calibrations, and repairs.
  • Meet with Quality Control Micro Team to review environmental issues and determine work orders required.
  • Work to eliminate excessive downtime to MFG by combining work when possible.
  • Review shift pass downs, emergency work, and new work requests to update customer on any new issues on a daily basis. Monitor parts updates for work requiring parts on orders
  • Coordinate and oversee HEPA testing campaigns.
  • Assist supervision and compliance in scheduling or communicating urgent or emergency work as needed
  • Categorize and monitor shutdown related work orders during production periods.
  • Assist planner with scheduling changeover, shutdown, and other projects as needed
  • Assist/lead shutdown related activities during shutdown periods
  • Contact and collaborate with external vendors to schedule work onsite
  • Daily Decisions:

    • Impacting and non-Impacting work to schedule
    • Compliance related: SARs, Change Request evaluation, potential quality events
    • Mechanic availability
    • Daily WO review/approval requiring exercise of judgment and critical thinking in regards to escalation of serious issues.
    • Tracking of daily work to advise on return to service with area and equipment owners

Position Requirements

  • Bachelors of Arts/Science degree highly preferred,
  • Minimum 2 years work experience in heavily regulated industry required (pharmaceutical preferred).
  • Solid understanding of GMP utility systems and manufacturing process equipment.
  • Strong working knowledge of GMP compliance requirements related to maintenance operations.
  • The employee must have the ability to perform a high volume of complex tasks with attention to detail.
  • Position requires exceptional organizational, communication, and critical thinking skills.
  • Position will require working within companies enterprise software systems including, CMMS, Trackwise, Oracle, Bio-G, Quickbase, and Compliance Wire. Experience with one or more of these systems is highly desirable.
  • Strong working knowledge of GMP compliance requirements related to maintenance operations.
  • Strong understanding of parts planning and inventory control practices highly desired.
  • Strong computer skills, including Microsoft Excel, Word, Project, PowerPoint
  • Ability to read and interpret P&ID and other technical drawings.

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

Please visit our website at www.randstadpharma.com

 
 


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