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Specialist, QC Instrument Management

Kelly Services

Fremont, CA
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Job Details

Job Title Specialist, QC Instrument Management

Jobid US15TPCH_BH1434457

Location: Fremont, CA, 94536, USA

Description **Specialist, QC Instrument Management**

**Location: Fremont**


+ Supporting the implementation and maintenance of Instrument Maintenance program.
+ Responsible for training site staff involved in Instrument Maintenance program, as required.
+ Will be a point of contact when working with internal partners.
+ Support QC SME for Data Integrity initiatives, continuous improvements, and related activities
+ Support QC customers in validation of new label equipment, or decommission of existing equipment/instrument in QC.
+ May be required to complete validation for new equipment or existing equipment by creating test protocols and gathering requirements URS, FRS, SDS, RTM, IQ, OQ/PQ
+ Support gap assessment of existing lab instruments/software used in QC per 21 CFR Part 11/Annex 11 and any remediation activities

+ Advance knowledge of validation of new equipment/instruments, changes to existing equipment/instruments, and/or decommissioning equipment/instruments; includes experience with system life cycle documents.
+ Experience validating or maintaining the following instruments: HPLC, UPLC, Capillary Electrophoresis, UV-Vis, TOC, Liquid Particle Counters, Microplate Readers, PCR System, FTIR
+ Experience validating or maintaining the following Software: Empower CDS, SoftMax Pro, 32 Karat, ChemStation, Biacore T200, DataPro2, LabWare LIMS
+ Experience implementing and maintaining Instrument Maintenance program.
+ Experience with Data Integrity and continuous improvement data mapping, gap assessments, remediation.
+ Experience remediating lab equipment, process, and software systems in compliance with 21 CFR Part 11 and GLP regulations.
+ Experience leading projects with history of achieving results and outstanding outcomes.
+ Advanced knowledge of relevant regulations and guidance’s required in order to act as a resource for colleagues.
+ Including but not limited to 21 CFR Part 11 and Annex 11.
+ Project management experience with the ability to manage multiple projects against given time-lines.
+ Excellent interpersonal, organizational, and time management skills with ability to manage multiple priorities to accomplish objectives and goals.

Bachelor s Degree in Biopharmaceuticals, Chemistry, or Biology or closely related degree.

**Why Kelly** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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