- Bristol Myers Squibb (Devens, MA)
- …no better place than here at BMS with our Cell Therapy team. The Quality Assurance Shop Floor (QASF) organization has responsibility for quality oversight and ... Shop Floor QA, Cell Therapy** shall be responsible for handling Quality Assurance Shop Floor internal compliance and documentation tasks, routine communication… more
- Bristol Myers Squibb (Devens, MA)
- …lives. Read more: careers.bms.com/working-with-us . **Position Summary:** The Senior Manager, Quality Systems - Change Control and Quality Risk Management ... (QRM) Process Owner is responsible for ownership and oversight of assigned quality systems per established local and global standards. This local process owner is… more
- Bristol Myers Squibb (Devens, MA)
- …BMS with our Cell Therapy team. This is a key role on the Shop Floor Quality Assurance team. As **Manager, Shop Floor Quality Assurance, Cell Therapy** , you ... lead a team of 4-8 employees. The Shop Floor Quality Assurance team is responsible for 24x7 Quality...to research, understand, interpret, and apply internal policies and regulatory guidelines + Proficient computer skills with knowledge of… more
- Hologic (Marlborough, MA)
- …love to have you on our team! **Knowledge:** + Strong understanding of FDA Quality System Regulations, particularly Design Control requirements. + In-depth ... + Detail-oriented and committed to maintaining the highest standards of quality and regulatory compliance. + Proactive and decisive, with the ability to… more
- Charles River Laboratories (Shrewsbury, MA)
- …inspections of routine processes to assure compliance with applicable GLP regulatory requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES: * Assure Charles River's ... compliance with applicable GLP . Communicate all identified compliance and quality risks to supervisor. * Perform data audits to assess that records are… more
- Oracle (Boston, MA)
- …Cloud SCM, Manufacturing, Quality , and ERP** integrations. + Knowledge of ** regulatory compliance processes** ( FDA , ISO, cGMP) and quality documentation ... initiatives, spanning **Innovation Management, Product Development, Product Hub, and Quality ** modules. You'll collaborate with cross-functional business teams (Manufacturing,… more
- North Coast Seafoods (Boston, MA)
- …contact between the production staff and the Quality department for all Quality , Food Safety and Regulatory issues + Responsible for filling out assigned ... The Quality Control Technician is responsible for testing seafood...motions: bending, twisting, squatting and reaching + Exposure to FDA approved cleaning chemicals + Exposure to temperatures: <32… more
- Abbott (Burlington, MA)
- …teams; and providing information on product complaints to various teams (eg Regulatory , Quality Engineering). **What You'll Work On** *Initiates and manages ... determine if a medical device report needs to be filed with various global regulatory agencies (eg, FDA , European Competent Authorities) and sends reports within… more
- Hologic (Marlborough, MA)
- …implement, and monitor a robust Internal Audit Program, ensuring compliance with FDA regulations, ISO standards, and other global regulatory requirements. If ... patient safety and innovation. **Knowledge** + Deep understanding of FDA Code of Federal Regulations (21 CFR 820), ISO...(eg, ISO 13485:2016, ISO 14971), MDSAP, and other global regulatory requirements. + Expertise in Quality Systems… more
- Sanofi Group (Cambridge, MA)
- … Regulatory Responsibilities** + Reviews and validates clinical data compliance with FDA , EMA, and ICH regulatory standards through weekly data review ... program strategy and the network of collaborators from research to operational, regulatory , and commercial functions. Success in this role requires the ability to… more