Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding ##### billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.
Viral Vector Services is an experienced viral vector CDMO supporting gene and cell therapies, and is focused on process and analytical development, and clinical and commercial supply. With more than a decade of experience, our 500-strong, highly skilled team has managed over 100 client projects delivering first-in-human clinical materials to accelerate our client's products from the laboratory to patients in need. We work in close collaboration with each client's team to deliver successful programs. Through this, we enable the delivery of novel medicines to improve patient health with the potential to cure diseases. The Viral Vector Service business within the Pharma Services Group enables biopharma customers to deliver life-saving gene and cell therapies to patients. This exciting addition strengthens our value proposition for pharma and biotech customers in a very fast-growing market.
Together with the acquisition of approximately 600 new VVS colleagues based in Massachusetts and Florida, we'll enable breakthroughs in science that improve patients' lives and bring hope for a healthier world!
The QC Specialist I will work with a team of Associates to ensure that the equipment needs of the Quality Control Analytical department are met at the Viral Vector Services (VVS) Alachua site. The core responsibilities include creating and tracking equipment work orders and maintaining equipment maintenance schedules each month. The QC Specialist I will ensure that all of the equipment is maintained and available for scheduled activity within the QC-AN lab space.
What will you do?
- Equipment Management
- Schedule preventive maintenance and calibration work each month internally.
- Printing work order paperwork from SAP
- Assigning work orders to members of the team
- Schedule preventive maintenance and calibration work each month with the Facilities group.
- Ensuring Facilities work does not disrupt QC testing.
- Complete monthly work orders in SAP.
- Open repair work orders and coordinate equipment repair through Facilities. Monitor the progression of the repair and update management.
- Coordinate the onboarding of new equipment including completing the necessary paperwork - User Requirement Specification (URS), Analytical System Impact Assessment (ASIA), and System Impact Assessment (SIA)
- Open deviations associated with equipment - out of tolerance incidents.
- Review equipment logbooks.
- Other duties as assigned by supervisor.
- May include material planning and acquisition.
This position is a M-F 8am-5pm role. Flexibility and overtime may be required on holidays and weekends to support project timelines.
How will you get here?
Education
• A Bachelor's degree in Life Sciences, Chemical/Biological Engineering, or an appropriate area of specialization.
Experience
• 1 year experience in a cGMP facility preferred
• SAP Equipment Maintenance experience is highly preferred
Knowledge, Skills, Abilities
• Proficiency with Microsoft office programs such as Word, Excel, and PowerPoint.
• Excellent technical writing and oral communication skills are required.
• Previous experience with Laboratory Information Management Systems and other Electronic Document Systems (eg. Trackwise, Documentum, etc) is recommended.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
• Ability to communicate/work in a high pressure/high paced environment.
• Ability to multi-task and function effectively as a member of a team.
At Thermo Fisher Scientific, each one of our 80,000 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.
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