- IQVIA (Boston, MA)
- …make a significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in Rare Disease or Pediatrics. Experience ... compliance with applicable regulatory, medical, and ethics guidelines. + Ensure high- quality , data-driven deliverables that meet the highest standards of medical,… more
- North Coast Seafoods (New Bedford, MA)
- …of Good Manufacturing Practices and food safety regulations + Understand OSHA/ FDA /USDA requirements in a seafood manufacturing environment + Intermediate computer ... the following motions: bending, twisting, squatting and reaching + Exposure to FDA approved cleaning chemicals + Exposure to temperatures: <32 degrees Fahrenheit +… more
- Nanobiosym, Inc. (Cambridge, MA)
- …steps. + Develop and implement validation protocols (IQ/OQ/PQ) that comply with FDA regulations. + Provide troubleshooting focus and direction for the team with ... + Participate in cross functional teams to improve safety, quality , efficiency and overall productivity + Monitor and validate...+ Recent experience with medical device development, in an FDA regulated (21 CFR 820) and/or ISO 13485 environment… more
- Abbott (Westford, MA)
- …meet new product introduction schedules, and enhance productivity and product quality . **MAIN RESPONSIBILITIES** + Provide leadership to engineering and facilities ... and monitor effectiveness of engineering systems and procedures to ensure compliance to FDA , GMP, and all other applicable agency regulations. + Ensure a safe work… more
- Bristol Myers Squibb (Devens, MA)
- …there's no better place than here at BMS with our Cell Therapy team. The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and ... oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. The **Senior Specialist, QASF, Cell… more
- Takeda Pharmaceuticals (Boston, MA)
- …of my knowledge. **Job Description** **OBJECTIVES:** + Ensures Global and R&D Quality processes are embedded and effectively implemented across CPMQ + Partner with ... to monitor the health of the QMS including the identification of systematic quality compliance risks and implementation of robust mitigation plans + Engage with CPMQ… more
- CGI Technologies and Solutions, Inc. (Burlington, MA)
- …and QA Lead will be responsible for managing the validation activities, quality assurance processes, and regulatory compliance for pharmaceutical projects. This role ... minimum of 8 years of experience in the pharmaceutical industry, specifically in Quality Management Systems (QMS), using tools such as Veeva or Trackwise, and… more
- Bristol Myers Squibb (Devens, MA)
- …process with key stakeholders. + Lead global investigations in collaboration with Global Quality Supplier Leads, BMS Site Supplier Quality , and SQE teams. + ... Provides support to the supplier development team preparing quarterly data for Quality Council and governance meetings. + Evaluates and improves supplier complaint… more
- System One (Harvard, MA)
- …Contract, Potential for extension or conversion to permanent Responsibilities + Provides Quality Assurance (QA) support to Devens Site and reporting Manger through ... quality review and approval of Investigations and Corrective Actions....Proven attention to details + Comfortable working in an FDA regulated environment. System One, and its subsidiaries including… more
- Teleflex (Chelmsford, MA)
- …medical technologies, Teleflex is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in ... totally Customer Centric in our unrelenting focus on Improving Quality , Service and Value as perceived by our customers....at all times. Assures compliance with GMP (ISO 13485, FDA 21 CFR 820, MDD 93/42EEC, and all applicable… more