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QA Specialist

Company: Hays
Location: West Sacramento
Posted on: November 19, 2022

Job Description:

The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply. A Biotechnology Company is seeking a QA Specialist in San Francisco, CA. Role Description --- Support all activities related to product manufacturing and release. --- Ability to achieve and maintain appropriate gowning requirements. --- To provide QA on-the-floor oversight and support to ensure compliance to GMP throughout the area. --- Perform walk-throughs and process observations. --- Perform line clearance and other QA functions in Production area. --- QA review and approval of Master documents (forms, procedures, etc.) related to Production. --- QA review and approval of electronic-executed Production Bach Records and associated records, assigning Production disposition to the produced batch. --- Manage and ensure that deviations, discrepancies, change controls, etc. related to Production are resolved and closed prior to batch release. --- Communicate lot disposition pending issues to Management. --- Escalate issues that may adversely impact timely release of product. --- Support raw materials and components sampling and shipment for testing. --- Oversee Rejected raw materials and finished product, ensure appropriate segregation, disposition and discarding of material/product. --- Support internal audits and inspections related to Production. --- Manage data integrity practices/ requirements in Production as established by Kite Global Policies, site procedures and regulations. --- Provide information for Product Quality Reviews and participate in review/approval of PQRs. --- Maintain metrics related to batch record review and disposition in support of the Management Review. --- Collaborates with cross-functional departments to ensure timely implementation of quality records. --- The standard work week for this position is M-F with an eventual shift to include occasional weekend work and/or week schedule as facility transitions to seven-day (4/10) manufacturing schedule. --- Perform additional duties as needed. Skills & Requirements --- 1 years of experience with BS degree in the biological sciences or related field. --- 3 years of experience in the biological sciences with HS diploma. --- Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards. --- Proficient in MS Word, Excel, Power Point and other applications. Familiarity with electronic systems for Batch Record, Quality Management Systems, Veeva and Smartsheet is a plus. --- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment. --- Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities. Why Hays? You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it. Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits. --- Medical --- Dental --- Vision --- 401K --- Life Insurance ($20,000 benefit) Nervous about an upcoming interview? Unsure how to write a new resume? Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting. Hays is an Equal Opportunity Employer including disability/veteran. In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570 Drug testing may be required; please contact a recruiter for more information. 1143932

Keywords: Hays, West Sacramento , QA Specialist, Other , West Sacramento, California

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