- Ascendis Pharma (Palo Alto, CA)
- …provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits + Work collaboratively with ... PV Vendor processing ICSRs for Ascendis Products. + Performs Quality Checks of processed ICSRs and provides feedback to...action (CAPA) as applicable. + Oversee regulatory and departmental compliance by ensuring timely processing of ICSRs in the… more
- Ascendis Pharma (Palo Alto, CA)
- …provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits + Contribute to the ... strategic input on the conduct of MAPs to ensure compliance with PV requirements + Ensuring SP/vendor oversight under...of PV Vendor Management by contributing to the Vendor Quality Agreements + Accountable for maintaining oversight over Source… more
- Charles River Laboratories (Hollister, CA)
- …and protection of the environment for the businesses. + Ensure facility compliance with applicable environment health and safety regulations. + Implement site audit ... program of the EHS&S compliance of the site, track and report status of...leader in the production and distribution of the highest quality research animal, with 1 out of 2 animal… more
- F & S Fresh Foods (Riverside, CA)
- …for verifying and documenting the requirements to ensure food safety. Execute daily quality activities to assess incoming materials, work in-process / product runs, ... quality , labeling, final inspections, analysis and testing of finished...safety best practices and processes. Ensures regulatory food safety compliance . + Verifies the daily production plan, and any… more
- Caldera Medical (Westlake Village, CA)
- …while also managing Corrective and Preventive Action (CAPA) activities to ensure compliance with FDA , ISO, and other applicable regulatory requirements. The ... Village, California Caldera Medical's Mission - To Improve the Quality of Life for Women! Message from the Hiring...and inspections by providing complaint records and demonstrating process compliance . CAPA Management * Lead and coordinate the CAPA… more
- Treasury Wine Estates (St. Helena, CA)
- …proud of our Treasury America's portfolio of brands that have tremendous heritage, rich quality , and a reputation for excellence across the globe. At TWE we are led ... for performing chemical analyses and providing scientific support to ensure the quality and consistency of products. This role involves using advanced analytical… more
- ThermoFisher Scientific (San Diego, CA)
- …Veeva Quality and Veeva RIM. + Supports Quality Assurance on quality systems and compliance activities, including audit functions, as needed. + Serves as ... stability samples for storage and testing. Conducts work in compliance with safety and regulatory requirements. May provides supervisory...and forced degradation studies. + Strong knowledge of GMPs, quality systems, and FDA and ICH guidelines,… more
- United Therapeutics (Sacramento, CA)
- …PV and enjoy partnering with vendors and partners to ensure the highest level of quality and compliance with respect to ISCR processing and reporting. The Lead ... Pharmacovigilance QC Specialist provides strategic oversight of end-to-end case safety quality , ensuring compliance , and quality in adverse effects,… more
- Abbott (Pleasanton, CA)
- …qualifications. You will manage project timelines, budgets, and deliverables, ensuring compliance with regulatory requirements. **What You'll Work On** + **Lead ... cross-functional project teams** to drive supplier quality initiatives, ensuring alignment with medical device regulatory standards (eg, FDA , ISO 13485). +… more
- Grifols Shared Services North America, Inc (San Diego, CA)
- …tasks to team members to ensure appropriate issue escalation occurs related to any quality or compliance issues. + Responsible for oversight of inspectors during ... Associate Director, QA Complaints to be part of our Quality Assurance team in San Diego, CA. The Associate...manufacturing processes in accordance with cGMP. + Knowledge of FDA and EU regulations, ISO requirements. + Skill in… more