- Astellas Pharma (Sanford, NC)
- …+ Review and approve Product Specification documents to ensure alignment with regulatory and internal requirements. ** Quality Systems and Compliance:** + Lead ... **Specialist, Quality Assurance for QC** Do you want to...associated protocols, reports, and deviations to ensure compliance with regulatory and internal standards. **Technical Leadership and Support:** +… more
- Hologic (Marlborough, MA)
- …+ Strong understanding of Quality Management Systems (QMS), CAPA processes, and regulatory requirements, including ISO 13485 and FDA QMSR. + Familiarity with ... Quality Engineer 2 Marlborough, MA, United States Are...and sustaining engineering. + Proven track record of supporting regulatory audits and maintaining audit-ready documentation. + Preferred: Experience… more
- Teleflex (Mansfield, MA)
- …to troubleshoot and resolve them. * Ensure Compliance: Adhere to all safety, regulatory , and quality standards in all tasks. * Additional responsibilities may ... experience of working in the medical device industry preferred * Experience with cGMP, FDA regulations, and ISO Quality Systems, strongly desired * Experience in… more
- BD (Becton, Dickinson and Company) (Temecula, CA)
- …and laboratory staff. + Participate in internal and external audits, including regulatory inspections. + Maintain and improve quality systems, including CAPA, ... **Job Description Summary** The Lab Services Quality Engineer is responsible for ensuring quality...verification testing activities for combination products in accordance with FDA 21 CFR part 210,211, 820, ISO/IEC 17025 and… more
- Nestle (Fort Smith, AR)
- …+ Assist in Quality Compliance Audits and work with external certification and regulatory parties as required such as USDA, FDA , Kosher, Halal and Organic ... eligible for Visa Sponsorship._ **POSITION SUMMARY:** To plan, coordinate, and execute quality activities related to the production, validation and release of IC and… more
- PCI Pharma Services (Madison, WI)
- …scientific discipline + Minimum 5+ year's relevant GMP experience. + Knowledge of FDA /ISO regulatory requirements as well as industry trends. + Computer ... and guidelines of cGMP. The Supervisor, QA Ops assists in maintaining quality systems, management of investigations, materials management and providing QA support in… more
- Endo International (St. Louis, MO)
- …work to bring the best treatments forward. Our shared values of Integrity & Quality , Innovation, Drive, Collaboration and Empathy guide our team and enable us to ... live their best life. **Job Description Summary** The In-Process Quality Engineer II- Stability performs essential duties in ensuring...sites + Manages and maintains stability samples under ICH, FDA , DEA and cGMP regulations + Pulls and delivers… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …+ Interest in clinical trial compliance + Interest in learning about audits and regulatory authority inspections (eg FDA , EMA, etc.) + Interest in learning about ... Santa Monica office, where you will be learning about our Research and Development, Quality (RDQ) team. You will have the opportunity to learn about Kite RDQ… more
- Curia (Springfield, MO)
- …provide data summaries to management + Utilize a thorough understanding of regulatory and compliance guidelines for the pharmaceutical industry + Interact with other ... + Escalate any cGMP concerns to Supervisors and to Quality Department as needed + Perform job functions in...+ Perform job functions in compliance with applicable US FDA regulations and current Good Manufacturing Practices. Education, experience,… more
- Actalent (Maple Grove, MN)
- … submissions. + Think critically and communicate clearly with R&D, Operations, and Regulatory Affairs. + Drive continuous improvement in quality systems and ... Senior Quality Technician Job Description: We are seeking a...skills with cross-functional teams and vendors. + Familiarity with FDA QSR, EU MDR, and ISO standards. + Sound… more