- Actalent (Minneapolis, MN)
- …. Responsibilities + Provide quality engineering support to US Operations to ensure compliance with FDA regulations. + Act as the first line support for ... Engineer plays a pivotal role in supporting and maintaining quality compliance within US Operations. This position...Excel, PowerPoint). Additional Skills & Qualifications + Knowledge of FDA regulations (21 CFR Part 820) and related standards.… more
- Astellas Pharma (Sanford, NC)
- …Health Authority regulations and guidance throughout the product lifecycle, supporting ongoing quality and compliance initiatives in BioPharma. + Participate and ... **QA Manager, Quality Risk Management** Do you want to be...work practices, and ensuring consistent application of QRM system compliance with Astellas local/global procedures and policies, and applicable… more
- WuXi AppTec (Middletown, DE)
- …processes for solid oral dosage, API, and aseptic small molecule production to ensure compliance with FDA , EMA, and other regulatory bodies. + Review and approve ... Host and facilitate external audits from regulatory authorities (eg, FDA , EMA) and clients, preparing documentation, coordinating site tours,...GMP, and related topics to foster a culture of quality and compliance . + Assist in the… more
- Mallinckrodt Pharmaceuticals (Webster Groves, MO)
- …Webster Groves commercial plant and projects + Serve as leading technical expert for key quality or compliance areas + Create, approve, and implement quality ... Job Title Mgr Quality Requisition JR000015209 Mgr Quality (Open)...The main result of the incumbent is to ensure compliance with cGMP, regulatory and internal requirements regarding the… more
- Kedplasma (Augusta, GA)
- …and procedures are followed by center personnel under the direction of the Quality Assurance Manager. Escalates any non- compliance that affects donor safety or ... of EU Guidance on Good Manufacturing Practice (GMP) and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...their supervisors. + Provides accurate reports of the facility's compliance to Quality Assurance Manager (QAM), Regional… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …as supplier quality engineering representative leading efforts to improve quality and compliance of components used in critical life-sustaining equipment. ... with standards and regulations such as ISO13485, IS09001, and FDA 21 CFR Part 820. * Must be currently... quality engineering representative leading efforts to improve quality and compliance of components used in… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …improvement. The Director collaborates with peers to support operations and supplier quality and compliance within each business unit. **Job Description** **We ... to the processes within the QMS to enhance both compliance and quality of products delivered from...the implementation of corrections and corrective actions. Provide supplier quality leadership during FDA and notified body… more
- Innovation Foods LLC (Millville, NJ)
- …exempt and non-exempt employees Duties/Responsibilities: Hands on management of the quality department ensuring daily production compliance of food safety ... Vacation and Sick Days Job Description - Director of Quality Location: Millville, NJ Shift: 1 st Shift Flexible...and government requirements. Act as a liaison for regulatory compliance agencies (USDA, FDA , Kosher, Halal, and… more
- Abbott (Sylmar, CA)
- …experience + Industry certification preferred. + Relevant experience, such as Quality , Compliance , Engineering, within a regulated environment, such as ... Our 114,000 colleagues serve people in more than 160 countries. **Job Title** **Software Quality Engineer II** **Working at Abbott** At Abbott, you can do work that… more
- Abeona (Cleveland, OH)
- …team management or leadership experience. + Deep knowledge of cGMPS, ICH Q9 ( Quality Risk Management), FDA regulatory expectations. + General knowledge of ... team management or leadership experience. + Deep knowledge of cGMPS, ICH Q9 ( Quality Risk Management), FDA regulatory expectations. + General knowledge of… more