4560 Horton Street Bldg. R-431 Emeryville, CA 94608
Bayside Solutions is seeking a QC Analyst to be part of our client’ s team in Emeryville. 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.
- 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:
- Use experience in all analytical assay method training to coordinate & perform critical material qualification & maintenance and/or other projects that are in addition to typical release, reference/reagent qualification and/or stability testing.
- To provide expertise to their designated QC group & to accurately assess the purity, potency, efficacy & other performance characteristics for the purpose of supporting both manufacturing & quality assurance in the production, release & monitoring of established product lines
- Coordinate & perform assays for their designated laboratory
- Routine in-process, final product (antigens) protein chemistry testing for release of product
- Routine in-process, final product (antigens) microbiological testing for release of product
- Routine testing for release of Raw Materials
- Routine testing for release of Seed Stock
- Antigen Stability, reference/reagent qualification testing
- Seedstock Stability testing
- Cleaning & or Process Validation testing
- Analytical Method Validation testing
- Product/Method development testing
- Use experience & method expertise to conduct troubleshooting
- May be assigned to assist with OOS Investigations,
- May be assigned to work independently on Validation, & Technical studies
- May be assigned to assist with the planning & execution of OE projects
- May be assigned to train staff on test methods
- Comply Site Environmental Health & Safety (EH&S) requirements
Summary of Qualifications:
- Bachelor’ s degree in Biochemistry, Molecular Biology, Immunology with 3 years’ experience or, MS degree in Science with 1 plus years’ experience
- At least 3 years’ experience in a regulated GMP testing laboratory
- Must have substantial (3 or more) assay testing experience in one of the main areas listed below:
- Protein chemistry methods such as Lowry, Bradford, BCA, SDS-PAGE, Western Blot, HPLC, Amino Acid Analysis, ELISA' s & in vitro diagnostic test kits.
- Microbiological methods such as Microbial Limits Test (bioburden), Sterility, Endotoxin, TOC, Microbial Identification, Contamination testing & Growth Promotion.
- Bacterial & Yeast Seedstocks testing methods such as Microscopic examination, viability, contamination, purity & phenotype testing, DNA Plasmid isolation & restriction digest testing.
- Environmental/Utility/facility Monitoring testing such as Sampling of & testing of manufacturing water by membrane filtration, viable & non-viable particulate testing of facilities & utilities, viable (surface) monitoring of manufacturing facilities, personnel & biological hoods, moisture & oil content testing of compressed gases
- Analytical/Microbiological Method Validation testing such as Bacteriosis & Fungistasis, linearity, specificity & robustness tests in protein chemistry, microbiology or complendial test methods
- Assay trouble shooting experience in their expert area
- Pharmacoepeial (compendial) test methods for Raw Materials such as, but not limited to; melting point, loss on drying, color & appearance, identity by FTIR, heavy metals, arsenic, residual solvents, chloride, sulphate, insoluble matter
- Proficient in MS Word, MS PowerPoint & MS Excel software
- Must be familiar with GMP' s & Quality System Regulations (QS Regs)
- Must have good time management, effectively prioritizing tasks for completion
- Individual must work in an ethical manner & ensure employees follow company ethics & compliance guidelines.
- Must meet the two (2) mission critical competencies: Customer Focus, Function/Technical Skills