QC Analyst I - 2nd Shift
300 Bel Marin Keys Blvd. Novato, CA 94949
Bayside Solutions is seeking a QC Analyst I – 2nd Shift to be part of our client’ s team in Novato. 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 Analyst I – 2nd Shift:
- 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:
- Responsible for performing microbiological, biochemical, and chemical evaluations of the manufacturing facilities, utilities, and equipment.
- Perform as a back-up for QC In-process and QC Microbial ID testing.
- Under direct supervision, the incumbent will be primarily responsible for performing environmental monitoring sampling and testing of the facilities, equipment, and utilities under cGMP guidelines.
- Responsible for performing biochemical and microbiological assays of samples under cGMP and GLP guidelines. Work assignments will encompass activities from routine to semi-routine in nature with the ability to recognize deviations from accepted limits and practices.
- Responsible for completing assignments in a timely manner, for assisting with troubleshooting, assisting with data trending, and for follow-up on any testing issues or excursions.
- Good record keeping, organizational, written and verbal communication skills are essential. Functional activities could include: supporting process validation studies, contributing to investigations, method validations, assay method/procedure development, reagent preparation, in-process microbiological and analytical testing, growth promotion of media, and microbiological identification testing.
- The position requires knowledge of, but is not limited to, aseptic technique, microbial challenge studies, bioburden determination, microbiological method validation, endotoxin, protein, activity, TOC, and other similar analysis methods.
- Must be willing to work second shift, overtime, weekends, and holidays as required.
Summary of Qualifications:
- Bachelor of Science or Bachelor of Arts in a Biological or Biochemical Science with at least 0-2 years of relevant laboratory experience or Associates of Science with at least 4 years of relevant laboratory experience.
- QC cGMP experience preferred.
- Experience in quality control practices, current Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).
- Demonstrated working knowledge related to specific functional activities.
- Ability to perform most tasks with supervision.
- Computer literacy is required.
- Experience with Microsoft Word and Excel required; experience with Access and PowerPoint a plus.
- Must have excellent record keeping, written and verbal skills.
- Experienced with microbiological methodologies and a variety of analytical instrumentation; capable of troubleshooting assays.
- Efficient in scheduling and facilitating.