- AbbVie (Pleasanton, CA)
- …Requirements: * Responsible for performing all duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, ... and all other international regulatory requirements with which ZELTIQ complies. Additional Information Applicable only to applicants applying to a position in any… more
- Gilead Sciences, Inc. (Foster City, CA)
- …that align with the Medical Affairs goals while ensuring compliance with ACCME, FDA , OIG, and other relevant guidelines (as well as Gilead policies and ... federal/state/local statutes and regulations). Staying abreast of industry trends and regulatory changes in the medical education is crucial to inform… more
- Gilead Sciences, Inc. (Foster City, CA)
- …CMC process development, issue CoTs, seek Specfication endorsement, and author relevant regulatory filings (Phase I/II IND/IMPD) for biologic drug substance and drug ... CMC Analytical Development/Operations and IND/IMPD Submissions + Strong Understanding of FDA and ICH guidelines relating to registration, quality, and compliance… more
- Bio-Techne (San Marcos, CA)
- …assessment and in alignment with ISO 14971:2019. Collaborate with R&D and Regulatory department personnel to align risks identified and mitigations to reduce and ... systems, utilities, and processes comply with the Food and Drug Administration ( FDA ) and industry standards. . Participate in management review meetings and/or… more
- Walgreens (Brea, CA)
- …analyzing results; and implementing changes. Helps ensure area Pharmacies adhere to regulatory compliance, standard operating procedures and FDA regulations. + ... Drives regional pharmacy financial performance by aligning business strategies with company financial goals. Implements and executes patient intervention pharmacy programs to maximize financial performance. + Supports efforts on enhancing patient experience by… more
- Kelly Services (Sacramento, CA)
- …data, and leading continuous improvement initiatives to ensure compliance with regulatory standards and high product quality within the pharmaceutical industry. ... environment. + Knowledge of cGMPs, Production Processes, Quality Systems, and FDA regulations + Proficiency in handling of electronic Quality Management systems… more
- Prime Matter Labs (Torrance, CA)
- …Degree in Chemistry or Chemical Engineering or a related field. + Familiar with regulatory standards such as ISO, GMP, or FDA . Preferred Skills: + ... Problem-solving and analytical skills. + Strong communication and teamwork abilities. + Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint). + Experience with Platforms Microsoft Teams & Monday.com. Physical Requirements: + Ability to lift and move… more
- J&J Family of Companies (Santa Clara, CA)
- …in compliance with the company's Design Control requirements and consistent with applicable regulatory requirements. + Partner with the Adv. R&D and PDP teams to ... company goals and objectives, policies and procedures, Quality Systems, and FDA regulations. + Other duties as assigned. **Qualifications** + Bachelor's Degree… more
- F & S Fresh Foods (Riverside, CA)
- …management team to ensure food safety best practices and processes. Ensures regulatory food safety compliance. + Verifies the daily production plan, and any ... action / preventive action) and follow up to Government (Federal - USDA / FDA / etc., State, County and City) inquiries. + Review documents and verify plant… more