PDS Tech, Inc. Jobs

Mobile pds Logo

Job Information

PDS Tech Inc QC Equipment Coordinator in Saint Louis, Missouri

PDS Tech, Inc. is seeking a Test Equipment Coordinator in Cedar Rapids, IA.

Summary:

The Scientist I (QC Equipment Coordinator) position will serve as a liaison between the QC group, TFS Engineering group, clients and vendors. The person will be responsible for following Current Good Manufacturing Practices (cGMP) and carrying out a variety of functions related to QC Equipment commissioning , maintenance and decommissioning activities, scheduling and planning.

What will you do?

  • Manage service and maintenance of all QC-owned equipment

  • Schedule all service for equipment, coordinating with contractor, service provider of TFS metrology group, including but not limited to PM scheduling, calibration

  • Asset management – commissioning of new QC equipment, removal and/or disposal of all QC-owned equipment that needs to be decommissioned

  • Build spreadsheets and other tools to accurately and efficiently track assets and scheduled equipment PMs

  • Follow up with QC management, TFS metrology, Engineering, contractor or service provider to ensure all work has been performed

  • Field repair calls, coordinate repair needs and negotiate and payment for all service performed and escort field service technicians on site, as needed

  • Prepare and maintain service records for QC equipment

  • Manage QC equipment commissioning program - including tracking of timelines, scheduling inter-departmental (Validation group, Metrology, Engineering, etc) meetings, providing update reports to QC management, and clearly communicating timeline risks and challenges

  • Coordinates with QC management on the evaluation of changes in the validated/equipment laboratory equipment, selection or evaluation of new equipment, and approving new or modified Calibration/PM criteria that impact the safety, identity, strength or quality of the product

  • Reviews the calibration/verification or PM data to ensure that the equipment is calibrated according to predetermined schedules and procedures

  • Independently writes and edits SOPs, Change controls, project plans, equipment calibration/PM procedures, and validation IQ/OQ protocols

  • Other duties within the quality department as required

  • Responsible for simple equipment administrator functions

  • Scheduling, technically completing PMs and work orders in SAP

  • Generating and processing paperwork for equipment changes in SAP

Required Experience:

  • More than 1 year in pharmaceutical or biopharmaceutical industry or experience as an equipment coordinator.

  • Experience with SAP.

  • Candidate job history should match daily responsibilities as close as possible.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

DirectEmployers