Randstad is the #1 HR Services company in the world. We have an exciting and immediate position open for a Quality Control Analyst to work in Berkeley, CA. In this position, you will perform activities associated with GMP release and stability testing of rFVIII products, including reagent qualification, performing instrument calibration, performing hands on testing and review, archiving GMP documents, and activities to maintain the laboratories in a compliant status. Our client for this position is one of the world's largest life science companies, focusing in healthcare, pharmaceutical and agricultural research. You must be available to work the graveyard shift.
Why Randstad? Randstad is a global leader in staffing. Randstad started in 1960 on the back of our founder Frits Goldschmeding's bike, and has since grown to be number one in the staffing industry globally.
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- Perform GMP testing and review of data and perform activities to maintain the laboratory in a state of compliance.
- Perform testing and data review for release, stability, and reagent qualification
- Perform work according to cGMPs
- Execute potency testing and review
- Perform instrument maintenance
- Report and review data in LIMS and SAP systems and routinely archive data
- Perform routine compliance checks against weekly checklist
Working hours: 11:00 PM - 7:00 AM
- Experience within a cGMP and global regulatory compliance organization
- Knowledge in biochemistry, specifically in rFVIII Potency testing and data analysis of rFVIII product.
- Knowledge on data integrity in areas such as following procedures / protocols, data recording rules, and data archiving
Bachelors Degree in Chemistry, Biochemistry, Engineering, or related field; 1+ years of laboratory experience preferred
Skill & Competency Requirements:
- Able to learn and perform tests and experiments.
- Able to perform accurate data entry and keep information organized.
- Adaptability to changing business requirements in a dynamic corporate environment is required.
- Takes appropriate action to ensure the integrity.
- Computer Skill (Microsoft Word, Excel) (PowerPoint is a plus)
- Good written and verbal communication skills, basic mathematical skills
This is a great opportunity in a positive, innovative work environment where all workers are treated with respect and diversity is accepted.
Benefits provided by Randstad include medical, dental, vision insurance; 401k; and holiday pay.
Relocation cost reimbursement is not available for this position.
Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Sexual Orientation, Gender Identity, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law. San Francisco Fair Chance Ordinance: Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.