- Cedars-Sinai (Los Angeles, CA)
- …and local agency requirements including the Food and Drug Administration ( FDA ) and local Institutional Review Board. **Primary Job Duties and Responsibilities** ... all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board. + Maintains research practices using Good… more
- Gilead Sciences, Inc. (Foster City, CA)
- …distribution + Host/Support NAPB audits of Asegua as well as supporting external FDA audits and internal audit programs, as required + Generate & maintain Standard ... manufacturing environment. + Experience in US market to include supporting FDA inspections. + Demonstrates proficiency in Good Distribution Practices (GDP), and… more
- J&J Family of Companies (Santa Clara, CA)
- …counter measures. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements (ISO), Company policies, operating procedures, ... outcome. + Experience working in regulated product and manufacturing environments (ISO, FDA , cGMP). + Knowledge of and compliance with applicable Quality System… more
- Gilead Sciences, Inc. (Foster City, CA)
- …interacts closely with external regulators/stakeholders as well as supporting external FDA audits and internal audit programs + Participate in developing/approving ... manufacturing environment. + Experience in US market to include supporting/hosting FDA inspections. + Demonstrates proficiency in Good Distribution Practices (GDP),… more
- ADM (Erlanger, KY)
- …manufacturing process in order to ensure compliance with the company policies, FDA cGMP, and industry standards. This role requires strong communication skills, ... working in a production environment + Follow all company policies, cGMP, Food Safety, FDA , USDA, GFSI, FSMA, OHSA Safety regulations, QMS and SOP / SSOPs. + Must… more
- Stanford Health Care (Palo Alto, CA)
- …clinic staff on pharmacy-related issues such as regulatory changes/compliance, FDA drug recalls, drug information, special programs, sample medications, ... levels. + Knowledge of other relevant regulatory guidelines (eg, CMS, 340B, FDA ). + Knowledge of theories, principles, practices and techniques of personnel… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …will be over the implementation of the Global Quality Systems Processes, compliance with FDA CFR, Part 820, Quality System Regulation and ISO 13485 and all other ... + Coordinates and leads audit activities with all global regulatory agencies (eg FDA , Notified Bodies, PMDA, NMPA etc.) + Creates and maintains Compliance department… more
- Cardinal Health (Indianapolis, IN)
- …functional units to achieve positive outcomes. + Assists Quality Management with FDA and other regulatory agency activities. + Demonstrates efforts to discovering, ... of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device) preferred + Possess an understanding of… more
- Coregistics (Acworth, GA)
- …enforce policies and procedures to meet federal, state, and local regulations ( FDA , USDA, and other applicable food safety laws), industry standards, and customer ... of food safety regulations, GMP, HACCP, and SQF standards. Familiarity with FDA , USDA, and other relevant regulatory bodies. + Strong leadership, communication, and… more
- WellSpan Health (York, PA)
- …and informed consent documentation requirements are met as per the GCP, FDA and IRB guidelines. Registers and accomplishes randomization of patients enrolled in ... and protection of the safety and welfare of human subjects (ie, DHHS, FDA and IRB research regulations, HIPAA privacy and research regulations and others as… more