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Quality Control Analyst IV

Bayside Solutions Novato, CA
  • Posted: over a month ago
  • Other

Bayside Solutions is seeking a Quality Control Analyst IV to be part of our client’ s team in the North Bay. 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.

Quality Control Analyst IV

Job Benefits:
  • 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:
  • Optimize, validate, and troubleshoot assays.
  • Perform biochemical/chemical analyses of samples to support process development, manufacturing investigations, and assay validation samples under cGMP to meet specified timelines.
  • Maintain lab in inspection ready state
  • Support lab equipment management
  • Prepare protocols, summaries and reports for routine and non-routine studies and analytical method validations.
  • Draft written QC test method SOPs for new assay methods.
  • Interface with contract facilities and other departments as necessary.
  • Well-developed laboratory skills for analysis of small molecule and biopharmaceuticals.
  • Comfort with coordinating the activities of other staff members and other groups.
  • At least two years in a cGMP laboratory; quality control experience preferred.
  • Experience in method development, optimization, qualification, validation, transfer.
  • Experienced with molecular biological and analytical methodologies such as ELISA, Capillary Electrophoresis, HPLC, Activity, Enzyme Kinetics, and Cellular Uptake.
  • Preferred experience with many of the following: HPLC, UPLC, Spectrophotometers, Plate readers, LIMS, Softmax Pro, Empower.
  • Knowledgeable and conversant concerning 21CFR, USP, EP, and ICH regulatory guidelines.

Summary of Qualifications:
  • B.S./B.A. in science (majors: biology, biochemistry, chemistry or similar) with at least 5 years’ experience in a relevant functional area, documentation of specialized training relevant to the position, and thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies.
  • M.S. with at least 3 years of experience in a relevant functional area and thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies.
  • Well-developed laboratory skills for analysis of small molecule and biopharmaceuticals.
  • Comfort with coordinating the activities of other staff members and other groups.
  • At least two years in a cGMP laboratory; quality control experience preferred.
  • Experience in method development, optimization, qualification, validation, transfer.
  • Experienced with molecular biological and analytical methodologies such as ELISA, Capillary Electrophoresis, HPLC, Activity, Enzyme Kinetics, and Cellular Uptake.
  • Preferred experience with many of the following: HPLC, UPLC, Spectrophotometers, Plate readers, LIMS, Softmax Pro, Empower.
  • Knowledgeable and conversant concerning 21CFR, USP, EP, and ICH regulatory guidelines.

Bayside Solutions

Address

Novato, CA
USA

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