- Taiho Oncology (Princeton, NJ)
- …or BS degree required with at least eight years related pharmaceutical /technical quality assurance or regulatory documentation experience,or equivalent ... experience. Knowledge, Skills, and Abilities: + Considerable experience in a pharmaceutical industry working in a regulatory or quality assurance department. +… more
- The US Pharmacopeial Convention (USP) (Rockville, MD)
- …terminologies and definitions, categorization and classification, labeling, expectations of quality , evidence evaluation, privacy and security, version control ). ... with the world's leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we… more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- …Drive for Results ORGANIZATIONAL RELATIONSHIP/SCOPE: Daily interaction with Manufacturing personnel, Quality Engineers, Quality Control Labs, Focus Factory ... experience, and competencies Experience: + Minimum 3-5 years of experience in Quality Assurance in a pharmaceutical manufacturing environment + Experience with… more
- Lilly (Concord, NC)
- …or equivalent degree in a scientific field + 4+ years' experience in Quality pharmaceutical manufacturing required + Previous experience with C&Q / Verification ... area process teams, including mentoring and training of new Quality staff + Resolve or escalate any compliance...and computer systems validation + Use process knowledge and control strategy to make quality decisions +… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …for data integrity and compliance with GCP guidelines and regulation, including Quality Control checks of the eTMF to ensure it is inspection ready. ... Quality Assurance and provides support to ensure the quality and compliance of studies conducted throughout...Minimum of 10 years' experience in medical device or pharmaceutical industry + Solid knowledge of ICH-GCP, applicable global… more
- Novo Nordisk (Bloomington, IN)
- …help us make what matters. Relationships Reports to Manager Essential Functions + Quality Compliance + Supports customer audits, including co-hosting audits and ... work tasks assigned + Executes procedures of moderate complexity with high quality + Intermediate understanding of pharmaceutical laboratory and/or production… more
- Lilly (Indianapolis, IN)
- …the site quality leader and the operations leader:** + Ensure compliance with local regulations and GMP requirements. + Authorize and amend written procedures ... performance. + Inspect, investigate, and sample to monitor product quality . + Monitor and control manufacturing and... unit can perform the activities, but the site quality leader maintains ultimate compliance responsibility.** **Key… more
- Lilly (Indianapolis, IN)
- …Inspecting, investigation, and taking samples to monitor factors that may affect product quality . + Monitoring and control of the manufacturing and laboratory ... sampling instructions and master batch records. + Ensuring robust control strategies are developed and maintained for the API... unit can perform the activities, but the site quality leader maintains ultimate compliance responsibility. **Key… more
- OnKure, Inc. (Boulder, CO)
- … Management System (QMS) and is responsible for ensuring GxP and QMS compliance . This position is responsible for ensuring Quality Programs are developed, ... members of the Quality Assurance team to provide enhancements to Quality Systems to improve efficiency, regulatory compliance , and reduce manual processes… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …observations and commitments related to Sterility Assurance for the Kite Network. **GMP Compliance and Quality Control :** + Ensure all sterility assurance ... of cell and gene therapy product manufacturing. This role ensures the safety, quality , and compliance of our products and processes through the development,… more