Bayside Solutions is seeking a Specialist, QC Instrument Management to be part of our client’ s team in Fremont. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Specialist, QC Instrument Management:
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- 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.
Summary of Qualifications:
- 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, etc).
- 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 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.
- Excellent interpersonal, organizational, and time management skills with ability to manage multiple priorities to accomplish objectives and goals.