QC Scientist I

Profile

We are seeking a QC Scientist I for a very important client.

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
Requirement:
The ideal candidate will possess the following qualifications:

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
How to Apply:
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Company info

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