- Charles River Laboratories (Wilmington, MA)
- …worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your ... quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.… more
- North Coast Seafoods (Chatham, MA)
- …the following motions: bending, twisting, squatting, and reaching + Exposure to FDA approved cleaning chemicals + Exposure to temperatures: <32 degrees Fahrenheit + ... Ability to work in wet and dry conditions + Ability to work Monday-Friday, weekends when needed + Ability to use tools and equipment, including knives North Coast Seafoods is an equal opportunity employer and does not discriminate against otherwise qualified… more
- Medtronic (Newton, MA)
- …efforts for Cardiac Ablation Solutions products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO 13485. + Serve as the Quality ... Core Team Member for Affera software releases. Coordinate quality team members and ensure accountability for completing functional work within program deadlines. + Review and approve Design History File and other documentation related to software and security,… more
- Cardinal Health (Boston, MA)
- …investigators participating in ongoing studies + Maintain current knowledge of FDA regulations and internal policies regarding Medical Drug Information, including ... any MSL presentations and Medical/Safety Review Committees + Provides pharmacovigilance support through collaboration with other internal stakeholders by collecting adverse event information, facilitating investigations of safety events, and identifying… more
- Merck (Boston, MA)
- …+ Knowledge of national and society treatment guidelines, clinical research processes, FDA regulations, and OIG, HIPAA and other ethical guidelines, laws, and ... regulations relevant to the pharmaceutical industry and its external stakeholder environment + Must be able to organize, prioritize, and work effectively in a constantly changing environment **Preferred capabilities:** + Recognition for scientific excellence… more
- Charles River Laboratories (Wilmington, MA)
- …worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your ... quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.… more
- Hologic (Boston, MA)
- …**Compliance & Safety** + Ensure all service activities comply with company policies, FDA regulations, and relevant standards (ISO, OSHA). + Promote and enforce a ... culture of safety and compliance within the team. **Training & Development** + Identify skill gaps and coordinate technical, regulatory, and product training for team members. + Support certification and ongoing professional growth initiatives. **Reporting &… more
- J&J Family of Companies (Danvers, MA)
- …+ Ensure that Design Controls are compliant with IEC 62304. + Ensure that FDA and other regulatory knowledge and experience is applied to risk management, software ... development and testing. + Participate in software development sprint cycles by supporting the software development team through attending SCRUMs, design reviews, code reviews and providing feedback on software verification and validation deliverables. +… more
- Bristol Myers Squibb (Devens, MA)
- …+ Experience working in biopharma, cell therapy, Good Manufacturing Practice (GMP), FDA regulated, or other regulated environments is a plus + Experience with ... predictive/waterfall project management processes and methodologies. PMP/CAPM certification a plus. + Basic knowledge of financial, operational, and business management principles + Proficient in Microsoft Outlook, Teams, Project, Excel, SharePoint,… more
- Aerotek (Danvers, MA)
- …safety rules, manufacturing procedures, company policies and procedures, QSR, and FDA regulations. **Essential Skills** + Attention to detail + Hand dexterity ... + Ability to learn and be trained on new skills and equipment + Experience with microscopes is preferred + Experience in cleanroom, medical device, or manufacturing is preferred **Additional Skills & Qualifications** + Good hand-eye coordination and manual… more