Analyst, QC I

Novato, California | Contract

Post Date: 11/07/2017 Job ID: 12201 Industry: Clinical & Scientific

Bayside Solutions is seeking an Analyst, QC I  to be part of our Client’ s team in Marin County. This is an opportunity to work with a local Biopharmaceutical company focusing on the developing and commercializing novel therapies for rare diseases.  

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. Their company has been recognized as one of the fastest drug developers in the industry and has also been recognized among the Top 10 World’ s Most Innovative Company’ s in 2015 & 2016.Their organization is fueled by their employee’ s passion and dedication to change the course of disease.

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.

Analyst, QC I

Job Benefits:
  • An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases.
  • 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:
  • Participates in product/project coordination internally, and with outside laboratories.
  • Manages shipments (inventory, packaging, documentation, and coordination) to partner laboratories.
  • Maintains laboratory supply inventories, and preparation for critical reagents.
  • Manages data trends for critical reagents and reference material.
  • Maintains the laboratory in an inspection-ready state.
  • Provides support for routine laboratory functions/chores for the QC laboratory.
  • Assists in the preparation/revision of routine and non-routine study protocols and reports and qualification documents.
  • Trains other analysts in areas of expertise on basic assays as well as more complex assays that are mastered.
  • Develops familiarity concerning cGMP, 21CFR, USP, EP and ICH regulatory requirements.
  • Interacts with other departments, including but not limited to  Shipping, Regulatory, Manufacturing, Microbiology, Quality Assurance, Analytical Chemistry, Formulation, and Process Development.
  • Performs, under direct or minimal supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines.
  • Works independently on assays that he/she has mastered and under direct or minimal supervision for those assays that are more complex.

Required Qualifications:
  • B.S./B.A. in Science (major in biology-biochemistry-chemistry) with at least  1 year of relevant laboratory experience or A.S. with at least 2 years of relevant
  • At least one year in a cGMP/GLP laboratory; quality control experience is preferred. 
  • Ability to follow written instructions and to perform tasks with direct or minimal supervision. 
  • Familiarity with use of a computer; e.g., Proficient in Windows, Microsoft Word, Excel, LIMS. 
  • Experience with bioassay and/or HPLC techniques. 
  • Good written, verbal, and communication skills.
  • Good documentation skills.
  • Demonstrates the ability to work independently
  • Detail oriented and organized

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