- J&J Family of Companies (Raynham, MA)
- …quality. + Ensure all quality activities comply with regulatory standards (eg, FDA , ISO) and internal policies, especially in areas impacting customer safety, ... satisfaction, and compliance . + Advocate for the adoption of emerging technologies...understanding of Quality Management Systems (QMS), risk management, and compliance standards + Demonstrated success leading cross-functional teams and… more
- North Coast Seafoods (Boston, MA)
- …Food Safety and Regulatory issues + Responsible for filling out assigned HACCP compliance documents + Conducts internal audits of plant and paperwork in conjunction ... Test and record measurements of seafood product attributes + Communicate quality or compliance concerns with urgency to QA leadership + Performs other related duties… more
- Dana-Farber Cancer Institute (Boston, MA)
- …an ability to learn and work within multiple sets of regulatory compliance requirements, and performing complex decision tree procedures in more advanced levels ... is performed within standards as established by FACT, the FDA , NMDP, and JC, and the specific protocol under...them in accessing appropriate staff and resources to ensure compliance and support the best possible outcomes. **This is… more
- Charles River Laboratories (Wilmington, MA)
- …change orders * Partner with the Revenue Recognition COE to ensure compliance (ASC 606) and alignment with financial policies * Monitor project-level profitability ... analysis, and billing processes * Support audit, SOX, and compliance requirements as needed * Identify and implement improvements...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- Cognizant (Boston, MA)
- …**Required Qualifications:** * **Deep Knowledge of GxP Regulations** Strong understanding of FDA , EMA, MHRA, and other global regulatory requirements (eg, 21 CFR ... Ability to author and review validation plans, traceability matrices, SOPs, and compliance documentation. Proven track record in preparing for internal and external… more
- Cognizant (Boston, MA)
- …yrs. of experience :_** **Deep Knowledge of GxP Regulations** Strong understanding of FDA , EMA, MHRA, and other global regulatory requirements (eg, 21 CFR Part 11, ... Ability to author and review validation plans, traceability matrices, SOPs, and compliance documentation. - Proven track record in preparing for internal and… more
- United Therapeutics (Boston, MA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... with vendors and partners to ensure the highest level of quality and compliance with respect to ISCR processing and reporting. The Lead Pharmacovigilance QC… more
- ZOLL Medical Corporation (Boston, MA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... content that promotes ZOLL's technologies through digital platforms and social media. Compliance & Budget Management : + Ensure all professional relations activities… more
- Sanofi Group (Framingham, MA)
- …Performs strategic planning and development activities for site CQ, including compliance , capacity, timeline and direction. + Align department objectives with ... (A) + Project < 5M (D) and Project > 5M (A) + Regulatory Compliance Strategies (A) + Process Improvement Initiatiaves (A) + Vendor Selection and Management (D)… more
- Fresenius Medical Center (Lexington, MA)
- …Change Orders in accordance with regulatory requirements. * Participates in compliance related activities, including quality system audits, labeling reviews, and ... verification/validation reviews. * Reviews advertising and promotional documents for compliance with applicable regulations. * Maintains corporate regulatory files… more