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PDS Tech Inc QC Scientist I in Saint Louis, Missouri

PDS Tech, Inc. is seeking QC Scientist I

How will you make an impact?

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

How will you get here?

Education

Minimum Bachelors Degree in a Biological Science or Engineering related field (Biology, Biochemistry or Chemistry preferred).

Experience

  • At least 1 year related experience in biopharmaceutical or pharmaceutical industry or equipment coordinator activities.

  • Knowledge of 21 CFR210/211

  • Working Knowledge of scientific principles for wide range of analytical techniques strongly preferred.

  • Routine use of MS Excel, MS PowerPoint, MS Project, MS Word and SAP is essential

Knowledge, Skills, Abilities

  • Strong written and oral communication skills.

  • Highly organized with attention to detail

  • Familiar with standard project management concepts, tools and responsibilities (objectives, scope, deliverables)

  • Strong organizational skills in monitoring QC equipment activities in progress

  • Excellent communication skills - Coordinate and communicate with QC management, Metrology, Facilities, Supplier Quality, Validation, IT, Engineering, Manufacturing, Contractor, service provider for QC equipment- related needs and issues

  • Working knowledge of cGMPs and Quality Control regulatory requirements

  • Knowledge of equipment used in a Quality Control laboratory - spectrophotometers, balances, pH meters, density meters, HPLCs/UPLCs, plate readers, computers, pipettes, and thermometers

Additonal Information

  • Role: Temp Only

  • Assignment duration? 6 Months contract

  • Possibility the assignment could be extended? Not currently

  • Hours of operation: M-F, 8a-5p

  • Interview process: One interview, MS Teams, 30 -60- minutes.

  • Required experience that a candidate must have for consideration: Minimum 1 year related experience for managing QC equipment in a GMP environment - looking for experience with equipment commissioning, qualification, preventative maintenance, etc. Role oversees the lifecycle of QC equipment in a GMP environment.

  • Intangible Skills: Strong Microsoft Office skills, Strong communication skills - hosting meetings, communicating with internal stakeholders and equipment vendors. Able to work independently and self-direct work to achieve equipment objectives.

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.

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