PDS Tech Inc QC Equipment Coordinator in Saint Louis, Missouri
PDS Tech, Inc. is seeking a Test Equipment Coordinator in Cedar Rapids, IA.
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
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.