QC Associate II
6397 Kaiser Drive Fremont, CA 94555
Bayside Solutions is seeking a QC Associate II 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.
QC Associate II:
- 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:
- Day to day duties will include but not limited to, LAL (Endotoxin) and Bioburden testing of in-process samples, raw materials, equipment rinses, WFI and bulk drug substance.
- Bioburden testing using Membrane Filtration method and Pour plate method. Biological indicator (BI) testing for autoclave validation.
- Gram staining, and microbial identification of Environmental Monitoring samples, and In Process Testing samples.
- Growth promotion testing and release of microbiological media.
- Assist in the preparation of periodic trend reports and analysis of microbiological data.
- Assist in laboratory investigations of microbiology excursions.
- Enter data in QC LIMS or other databases in a timely manner.
- Perform other miscellaneous Lab maintenance activities.
- Should be able to lift, carry, push or pull up to 50 pounds occasionally.
- Assist in revising Standard Operating Procedures.
- Perform GMP document reviews as required.
- Ensures sampling, testing and release timelines are met.
- Follows well-defined and established procedures and best practices.
- Must have experience with GMP and GDP.
Summary of Qualifications:
- Bachelor’ s degree in science (preferably in microbiology).
- 2 or more years of experience in cGMP regulated industry (Preferably in QC Microbiology lab).
- Demonstrates proficient computer skills (i.e. documentation systems, databases and spreadsheets), knowledge of Microsoft applications, must be able to use computers to perform data-entry functions etc.
- Demonstrates excellent interpersonal and communication skills (both written and oral).
- Demonstrates ability to work under minimal direction and as part of a team.
- Demonstrates strong attention to detail.
- Demonstrates good facilitation, organizational and problem solving skills.
- Must have experience with Pipetting.
- Must have working knowledge of relevant Standard Operating Procedures, U.S. and E.U. Good Manufacturing Procedures and other regulatory requirements.
- Must be able to work flexible hours.
- Must be able to work stagger shift of Sun-Thu 11-8 or Tues - Sat. 8-5.