- Amgen (Thousand Oaks, CA)
- …Drug Product Technologies organization. Working with the Principal Engineer Process Validation Manager of Amgen Thousand Oaks (ATO) Process Engineering, this role ... excellence in aseptic processing, technology transfer, process characterization, process validation and continuous process verification. This role will be based… more
- Bio-Techne (San Marcos, CA)
- …Quality representative for new equipment program. Evaluate new equipment for validation requirements. Act as a reviewer/approver on equipment validations performed ... . Schedule and lead periodic cross-functional meetings to review the Validation Program. Recommend process/equipment candidates for re- validation based on… more
- Actalent (Irvine, CA)
- …Solidworks, Design, Process development, medical device, research & development, validation , verification, protocol writing, product development engineering, fda ... Full cycle new product development from concept to commercialization Design validation and verification testing Solidworks design Equipment engineering and transfer… more
- Actalent (Santa Clara, CA)
- Main duties will revolve around equipment validation for their lab, but it is a small team so you will get exposure to all aspects of Quality Engineering. ESSENTIAL ... RESPONSIBILITIES + IQ, OQ, PQ of equipment and equipment validation for the lab move. + The position is...site procedures. * Participate in third party (Notified Body, FDA ) audits as required * May manage key quality… more
- Abbott (Menlo Park, CA)
- …assure specifications can be met before final release + Test Method Development/ Validation + Design Verification/ Validation + Corrective and Preventative Action ... Ensure compliance to product specific standards, cGMP, QSR, US FDA , ISO, IEC, UL, EN, and MDD/MDR requirements and...design and development. + Experienced in ISO, EU and FDA regulations, standards and guidance as applicable to risk… more
- Cordis (Santa Clara, CA)
- …identifying trends and areas for improvement. + Support the implementation and validation of manufacturing processes to meet quality requirements. + Participate in ... risks. + Contribute to the creation and execution of validation protocols for equipment and processes. + Assist in...quality. + Support regulatory compliance by ensuring adherence to FDA and other relevant standards. + Conduct internal and… more
- Bayer (Berkeley, CA)
- …including a current understanding of USP/EP, cGMP regulations, ICH, and FDA Guidance Documents. Provide support during internal/external audits; + Ability to ... and sampling, assays, specification setting), Supply Chain and Warehouse Management, Validation , and Quality Systems (Deviation and CAPA management, Change Control,… more
- Fortive Corporation (Irvine, CA)
- …technical documentation, including engineering drawings, design specifications, SOPs, and validation protocols. Apply FBS (Fortive Business System) tools and lean ... productivity. Ensure all designs and projects are compliant with GMP, FDA , ISO 13485, and applicable regulatory requirements. **Required Qualifications:** Bachelor's… more
- Element Materials Technology (Santa Fe Springs, CA)
- …routine QA activities to ensure compliance with applicable regulatory requirements (eg, FDA 21 CFR Part 11, 210/211, ISO 17025) and internal quality standards. ... and cGMP. + Participate in QA review of equipment qualification and method validation documentation prepared by technical staff. + Ensure that controlled records are… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …Quality Management Strategic initiatives, such as Inspire Quality. + Software validation + Quality functional support for implementation of electronic systems that ... Minimum ten (10) years progressive experience in Quality Assurance within an FDA regulated industry; QA administration and planning experience required. + Minimum 3… more