Full-Time Scientist II, QC Equipment Coordinator
Job Description
*Location/Division Specific Information*
This position supports the QC Analytical team for our Biologics Division in St. Louis, MO.
*How will you make an impact?*
The Scientist II (QC Equipment Coordinator) position will serve as a liaison between the QC group, TFS Engineering group, clients and vendors. He/She 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, contractor or service provider to ensure all work has been performed
- Field repair calls, coordinate repair needs and negotiate payment for all service performed
- 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 SOPs, Change controls, project plans, equipment calibration/PM procedures
- Serves as a subject matter expert during regulatory and/or vendor audits, through understanding of EU and US regulatory requirements for laboratory equipment
- Assure all laboratory equipment procedures are aligned with the current compendia (such as USP/NF, EP or any other regulatory reference) requirements.
- Other duties within the quality department as required
*How will you get here?*
- Minimum Bachelors Degree in a Biological Science or Engineering related field (Biology, Biochemistry or Chemistry preferred).
*
- At least 4 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, and MS Word 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, Contractor, service provider for QC equipment- related needs and issues
- Working knowledge of cGMPs and Quality Control regulatory requirements
At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Apply today! [http://jobs.thermofisher.com](http://jobs.thermofisher.com)
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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