Specialist, QC Instrument Management

Fremont, CA Contract Duration: 12-36 months Rate: Negotiable Salary: NA, $1.00Responsibilities: Excellent employment opportunity for a Specialist, QC Instrument Management in the Fremont, CA area. Supporting the implementation and maintenance of Fremont 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 inititatives, continuous improvements, and related activities Support QC customers in validation of new labl 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 Experience: Bachelor's Degree in Biopharmaceuticals, Chemistry, or Biology (or closely related degree) with 5 + years of relevant industry experience. 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. Advanced knowledge of relevant regulations and guidances 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.

Created: 2026-04-15