Data Management and Calibration Specialist

Kelly® Science & Clinical is seeking a Data Management and Calibration Specialist for a contract-to-hire opportunity with a leading molecular diagnostics company at their Bothell, WA location. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology realm.

Workplace: Onsite in Bothell, WA 

Position Title: Data Management and Calibration Specialist

Position Type:  Contract-to-hire 

Pay rate: $30-37/ hour.

Company: Kelly® Science & Clinical

Overview 

We are currently seeking a Calibration Specialist who will be responsible for managing the calibration program for Manufacturing, QC and R&D. The Calibration Specialist is responsible to ensure all equipment calibrations are performed per requirements for the Cepheid Bothell campus.  This position is in the Quality department and will contribute to improvements in compliance to FDA’s Quality System Regulation and ISO 13485 Standard. This position will make significant impact to the Bothell site by supporting facility growth and implementing improvements to increase the efficiency, delivery, and consistency of the calibration program.

Responsibilities

• Ensure calibration schedule adherence to meet cGMP compliance, production and R&D requirements. Communicate calibration due dates to equipment owners. 
• Schedule on-site calibration events and coordinate off-site calibrations with equipment owners and external service providers to minimize downtime.
• Provide training to equipment owners and visiting service providers.
• Investigate equipment out-of-tolerance events.
• Maintain calibration records in the asset management system, hard copy records management, and prepare reports and metrics.

Qualifications

• Bachelor’s degree in a life science discipline 
• 0 – 2 years of relevant work experience
• Prior science or chemistry knowledge to apply understanding of laboratory equipment.
• Conceptual knowledge of practices and procedures within a regulated industry to ensure GDP/GMP and compliance.
• Demonstrated excellent time management skills, attention to detail, and effective communication across the organization and with external service providers.

Preferred

• Medical Device with ISO 13485:2016 standards, FDA GMP regulations, or healthcare experience. 
• Using calibrated equipment 
• Knowledge of Blue Mountain Regulatory Asset Management software.
• Chemistry production or analytical work (especially oligonucleotide chemistry)

Why Join Us:

• Competitive compensation package and potential for permanent placement following the temporary period.
• Opportunity to work at the forefront of biotechnology innovation in a collaborative and dynamic environment.
• Access to ongoing career development and networking opportunities through Kelly® Science & Clinical's expansive network of industry experts and recruiters.

If your qualifications align with the requirements of this role, we invite you to apply and take the next step in your career journey. Rest assured, even if this opportunity isn't the perfect match, your profile will remain within our network, ensuring you're connected to a wealth of future opportunities in the field of science and clinical research.