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Compliance Specialist Principa

Company name
Genzyme Corporation

Northborough, MA

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Department Description: QA Disposition is responsible for the disposition of raw materials and finished product at Sanofi's Northborough Operations Center, a state of the art multi-product labeling, packaging and distribution facility.QA Disposition's main function is as follows: 1)Ensure GMP's and market regulations are adhered to during finished product packaging operations. 2)Ensure all testing and documentation for raw materials meets criteria per applicable Material Specifications Position Overview: In support of our main function, our additional areas of responsibility include; issuing and reviewing\/approval of production records and related support documents, validation study review\/approval,SOP review\/approval, finished product inspection, deviation\/CAPA review\/approval, external department support activities and final disposition of finished product and raw materials for distribution. This position is responsible for performing a variety of complex tasks working independently with little to no supervision and in compliance with cGMP's to support Packaging operations and raw material disposition. Responsibilitiesinclude: Performingfinished productdispositionin accordancewithGenzymeSOP's, in-house productspecificationsandmarketregulations Reviewing and approving validation protocols and change controls Authoring, revising and reviewing SOP's through LiveLink System Utilizing TrackWise to perfom QA review\/approval of deviations and associated CAPAs Performing compliance walkthroughs and statistical analysis of results to process or equipment compliance to FDA and GMP requirements Interpreting very complex, explicit documentation for new and current procedures and FDA enforcementactions\/trends Completing analysis, identifying issues and providing recommendations for compliance improvements Completing Quality Events in Catsweb Participate in audit readiness Responsible for QA project management Development and training of new staff as needed Participate in specialized projects both within Quality and cross-functionally Perform all aspects of Quality Disposition as it pertains to release activities that will include, but not limited to the dispostion of raw materials and final packaging\/component lots Support additional areas of Quality Dispoistion including Rejected, Quality Hold and Non-Conforming Materials Maintain Material Master Data in ERP system Effectively demonstrates an understanding of GMPs & how it applies to specific responsibilities. Following accurate oral & written procedures in performing QA tasks Staying up-to-date on training of all procedures Routinely and safely handle high value product vials in various stages of packaging completion Maintaining orderliness of work areas Monitoring operations to ensure compliance with process specifications Adhering to Genzyme's safety procedures and guidelines Qualifications: Basic: Bachelor's degree and10 years of experience in Quality and\/or Operations experience in a cGMP \\ManufacturingEnvironmentor equivalent Preferred: Bachelor's degree with 8-10 years Quality and\/or Operations experience in a CGMP Manufacturing Environment or equivalent Industry bio-pharmaceuticalexperience Quality subject matter expert Knowledgeof cGMPregulationsfor US,EUandothermarkets Experience with cGMP documentationreview Experience training and mentoring colleagues Ability to prioritize and successfully manage multiple competing activities Led project teams Led development and training and staff Performed all aspects of the deviation\/investigationsworkflow Clear communicator; strong verbal, written and technical writing skills Effective time management, detail oriented, organizational skills, teamwork andcollaboration Trackwise system experienced Experience with Management Inventorysystem Experience with Quality database system, ie. Livelink and Catsweb Sanofi Genzyme, the specialty care business unit of Sanofi, focuses on rare diseases, multiple sclerosis, oncology, and immunology. We help people with debilitating and complex conditions that are often difficult to diagnose and treat. Our approach is shaped by our experience developing highly specialized treatments and forging close relationships with physician and patient communities. We are dedicated to discovering and advancing new therapies, providing hope to patients and their families around the world. Learn more at\u00a0 Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare.\u00a0 Genzyme Corporation (a Sanofi company) and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Sanofi, Empowering Life

Company info

Genzyme Corporation
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Company Profile
Genzyme is committed to discovering and delivering transformative therapies for patients with rare and special unmet medical needs, providing hope where there was none before. Corporate Overview Genzyme has pioneered the development and delivery of transformative therapies for over 30 years. Founded in 1981 in Boston, Massachusetts, Genzyme evolved from a tiny start-up with just a handful of employees to one of the world's leading biotech companies. Acquired by Sanofi in 2011, Genzyme now benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. We've kept our roots in the Boston area: our headquarters, Genzyme Center, is located in Cambridge, Massachusetts, home to venerable universities, teaching hospitals, and a thriving biotechnology community. But we also operate in every other region of the globe.

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