Specialist, QC Instrument Management
6701 Kaiser Dr Fremont, CA 94555
- Supporting the implementation and maintenance of BI 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 initiatives, continuous improvements, and related activities
- Support QC customers in validation of new lab 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 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) with 5 + years of relevant industry experience.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.