- Regeneron Pharmaceuticals (Tarrytown, NY)
- …efficiency and impact. + Ensuring analyses and documentation are of the highest scientific quality and regulatory compliance. **This may be the right role for ... analyses supporting regulatory submissions and engaging directly with agencies (eg, FDA , EMA, PMDA). + Hands-on experience with a broad range of quantitative and… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …, Manufacturing) to ensure seamless product development. + Provide guidance on quality aspects across regulatory filings related to specifications, acceptance ... organizations and external collaborators. + Ensure compliance with all relevant regulatory requirements for injectable products, including ICH guidelines and FDA… more
- Vanderbilt University Medical Center (Nashville, TN)
- …work quality before delivery and asks relevant questions to meet quality standards. - Fulfills Safety and Regulatory Requirements: Demonstrates basic ... safe work environment. + Uses approved cooking methods to prepare quality foods for patients/retail to achieve customer satisfaction. + The responsibilities… more
- Grifols Shared Services North America, Inc (Council Bluffs, IA)
- …activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts ... daily operational plans to achieve center performance targets related to donor throughput, quality , and productivity. + Partners with Center Manager and Quality … more
- Abbott (Sturgis, MI)
- …the organization. + Able to work independently. **Preferred Qualifications** + Knowledge of FDA Quality System Regulations In compliance with federal law, all ... for non-conformances, potential non-conformances, and/or deviations, as output from ADC's Quality System. + Facilitates the investigation process to ensure that… more
- Actalent (Redmond, WA)
- …deviation reports. + Maintain facility GMP compliance and assist in ensuring regulatory inspection readiness. + Collaborate with team members to ensure project ... multidisciplinary project teams. + Serve as a liaison between manufacturing, quality , and process development teams. + Communicate compliance strategy and rationale… more
- DRT Strategies, Inc. (Silver Spring, MD)
- …make vision a reality. Project Description: This project is designed to support FDA CDER Office of Quality Surveillance (OQS) with developing and implementing ... and innovative techniques to achieve comprehensive surveillance and estimate the state of quality . The objective of this project is to conduct thorough research and… more
- North Coast Seafoods (Boston, MA)
- …their respective teams in the Environmental Monitoring program, working with Quality Assurance, Production, and Maintenance to ensure a healthy plant environment. ... safety and workspace cleanliness. This enables us to produce top- quality seafood products, at high volume, to customers all...activities to meet and exceed the internal and external customer/ regulatory expectations + Review and complete all of the… more
- Grifols Shared Services North America, Inc (Fayetteville, NC)
- …activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts ... daily operational plans to achieve center performance targets related to donor throughput, quality , and productivity. + Partners with Center Manager and Quality … more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …complex microbiological testing and environmental monitoring (EM) in compliance with cGMP, USP, FDA , and internal quality standards. This position is in a ... implement continuous improvement opportunities to optimize workflows in the quality control microbiology laboratory. OVERALL JOB RESPONSIBILITIES: Operational Excellence:… more
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