Sr. Specialist, Quality Assurance

Job DescriptionQuality Assurance Senior Specialist - (Contract) - Hybrid - CACalifornia Biotech seeks a Quality Assurance Senior Specialist for a hybrid contract opportunity near Fremont for a 6-month contract with possible extensions. The ideal candidate will have 3+ years' hands-on QA experience working within Quality Systems in a GxP regulatory environment. This includes Utilities, Facilities, Equipment, Analytical Instruments and Computerized Systems. Additionally, this person must have experience in data integrity programs while interacting cross-functionally with QC, Manufacturing, Facilities, IT, Supply Chain and Regulatory Affairs. Opportunity requires hybrid onsite meaning LOCAL CANDIDATES ONLY & NO RELOCATIONS FOR PROJECT.Requirements: BS Degree or similar area of study. Availability to be onsite within a hybrid role 2 to 3 days weekly; meaning local to the area. 3+ years hands-on QA expertise within a Biotech or pharma organization and within a GxP environment. Proficiency in all Microsoft Office Applications. Lab Systems and Veeva are both a plus.Responsibilities Performing various QA activities while ensuring compliance with organizational procedures and US/International regulatory requirements for drug products. Coordinating and tracking closure of quality records to include change controls, deviations, CAPAs, quality investigations, and more. Providing quality oversight for Facilities, Utility Systems, Equipment (FUSE) Qualification in addition to instrument qualifications (AIQ) and Computerized Systems Validation/Assurance (CSV/CSA), while applying risk-based methodology to validation and qualification efforts according to GxP regulations. Overseeing Quality System/Equipment implementations and all activities related to Analytical Development method projects. Providing oversight of quality of activities and quality records to include deviations, CAPAs, and change controls, within GxP Facilities, Utilities, Equipment, Analytical Instruments, and Computerized Systems. Driving data integrity best practices and awareness across the Data Integrity Program while ensuring maintenance and compliance across the entire data lifecycle for GxP Operations. Supporting continuous quality systems improvements by authoring new and existent procedures and forms. Benefits: A 6-month hybrid contract with potential extensions. The opportunity to work W2 with or without benefits or 1099. The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet domain (@theplanetgroup.com or @launchcg.com) - and not a domain with an alternative extension like .net, .org or .jobs.The Planet Group and our companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.