Quality Control Analyst I
46 Galli Road Novato, CA 94949
Bayside Solutions is seeking a Quality Control Analyst I 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 I
- 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:
- The Quality Control Analyst is responsible for performing microbiological, biochemical and chemical tests of in-process product, equipment, and manufacturing facilities. The incumbent will be responsible for performing microbiological and analytical testing under cGMP guidelines.
- Functional activities may include: performing a wide variety of tests for microbiological, biochemical, and chemical assays, supporting process validation studies, conducting investigations, analytical method or equipment validation, assay method/procedure development, and reagent preparation.
- The position requires knowledge of but is not limited to: HPLC, Enzyme activity, protein by UV spectrophotometry or Bradford/BCA, kinetic chromogenic endotoxin, bio burden determination, Total Organic Carbon, microbial identification, aseptic techniques, microbial challenge studies, microbiological method validation, and other similar analysis methods.
- Work assignments will encompass activities from routine to complex in nature with the ability to recognize deviations from the accepted or routine practice.
- The incumbent will be responsible for completing assignments in a timely manner, for assay troubleshooting, data trending, and for follow-up on any testing issues. The incumbent should be able to work independently and prioritize multiple tasks.
- Good record keeping, organizational, written and verbal communication skills are essential. The incumbent must be willing to work second shift, overtime, weekends and holidays as required.
- Perform microbiological/ biochemical/ chemical analyses of in-process product, facility and utility testing under cGMP to meet specified timelines.
- Assist with the preparation of investigations, technical reports and trend reports.
- Support method validation, transfer, routine, and non-routine study protocols.
- Control laboratory inventories.
- Maintain the laboratory in an inspection ready state.
- Provide backup support of analytical chemistry/biochemistry assays for Analytical and Raw Materials Groups.
- Provide on call coverage for Action level conditions to support production testing and quality control laboratory equipment.
- Must have a quality service attitude and be willing to work additional hours to meet production or laboratory requirements when necessary.
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 beneficial.
- Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices.
- 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 the execution of routine and non-routine testing.