- Envista Holdings Corporation (Thousand Oaks, CA)
- …for purchasing and negotiating materials, equipment and supplies from qualified ISO/ FDA vendors and maintaining the related documents and records. He/She will ... GL accounts, and confirm vendor acknowledgment. + Ensure vendor compliance with company procedures, including onboarding documentation, quality certifications, and… more
- J&J Family of Companies (Irvine, CA)
- …AR/VR, Telementoring, + Maintain the required training documents that fulfill the FDA training commitment for TRUFILL n-BCA Liquid Embolic System and Enterprise ... and processes, and corporate brand style and standards, including compliance requirements. **Qualifications:** **Required:** + Bachelor's degree is required. +… more
- CSL Plasma (Stockton, CA)
- …2 In compliance with SOPs and Food & Drug Administration ( FDA ) guidelines performs venipuncture to begin pheresis process. 3 Evaluates vein performance of ... **Job Description** 1 In compliance with Standard Operating Procedures, (SOPs), performs all aspects of the pheresis procedure and plasma collection, including donor… more
- ThermoFisher Scientific (San Diego, CA)
- …internal stability samples for storage and testing. Conducts work in compliance with safety and regulatory requirements. May provides supervisory role for ... RIM. + Supports Quality Assurance on quality systems and compliance activities, including audit functions, as needed. + Serves...studies. + Strong knowledge of GMPs, quality systems, and FDA and ICH guidelines, such as ICHQ1. + Highly… more
- Catalent Pharma Solutions (San Diego, CA)
- …is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, consumer, and Catalent employee.** **The ... SOPs and Catalent systems applicable to work performed. Apply ICH and FDA guidance. Proactively request assistance when needed to prevent deviations and… more
- Kelly Services (Anaheim, CA)
- …will also serve as the Management Representative and Person Responsible for Regulatory Compliance under 21 CFR Part 111 and 117, while providing leadership and ... + Monitor the complete manufacturing and QA/QC process to ensure conformance and compliance and manage the Quality System in accordance with applicable local and… more
- Abbott (Alameda, CA)
- …QA representative on new and on-market product design projects to ensure compliance with the internal design control process and external standards and regulations. ... File (DHF) and Device Master Record (DMR) are in compliance with regulatory standards and quality management policies and...pharmaceutical products. + Knowledge of medical device standards including FDA QSR, ISO 13485, ISO 14971, 21 CFR Part… more
- Lactalis American Group Inc. (Tulare, CA)
- …such as but not limited for ensuring the optimal performance, reliability, and compliance of all processing and packaging systems at the facility. This role supports ... team to analyze chronic equipment issues and develop long-term solutions. + Ensure compliance with all applicable regulatory and safety standards (eg, FDA , OSHA,… more
- United Therapeutics (Sacramento, CA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... with vendors and partners to ensure the highest level of quality and compliance with respect to ISCR processing and reporting. The Lead Pharmacovigilance QC… more
- Takeda Pharmaceuticals (Van Nuys, CA)
- …and executing daily maintenance activities at the LA Site while ensuring compliance with current Good Manufacturing Practices (cGMP), Environmental Health and Safety ... emergency and urgent work orders. + Coordinate and oversee contractors, ensuring compliance with site standards and requirements. + Monitor and maintain equipment,… more