Validation/Compliance Specialist Associate in Boston, Massachusetts For Sale

Title: Validation/Compliance Specialist Associate Location: United States-Massachusetts-Framingham Other Locations: Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme 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. Learn more atwww.genzyme.com. Job Title: Validation/Compliance Specialist Associate Department Description: The Manufacturing Systems and Information Technology (MSIT) support function at Framingham Biologics manufacturing sites is responsible for ensuring that the computer and automation systems and associated infrastructure used in the manufacture, storage, testing, and distribution of Genzyme products are fit for purpose in accordance with Genzyme Corporate standards and industry regulatory requirements. This encompasses work processes that originate with the identification of a new or revised system, the design, installation, verification and validation of the system, the maintenance of the system in its commissioned/qualified/validated state and the retirement of the system at the end of its life. Position Summary: The Validation/Compliance Specialist Associate is responsible for performing IT compliance and validation related tasks and projects at the Genzyme Framingham Biologics manufacturing sites for the site IT, automation engineering and manufacturing execution system groups in the MSIT department. Primary duties include performing periodic internal audits to ensure compliance with department procedures, assisting in department documentation generation, routing, review and approval, assisting in qualification and qualification/validation activities, supporting MSIT department engineers and administrators in day-to-day support activities and performing other tasks of similar nature and level. Core Responsibilities: ** Conduct or assist in conducting periodic audits of user access to GxP systems and applications, and remediate or assist in remediating compliance issues. ** Process or assist in processing and managing user access forms for department supported systems. ** Conduct or assist in conducting periodic audits of systems and procedures to verify compliance and remediate or assist in remediating compliance issues. ** Generate, track and report on compliance to quality system metrics, such as training and deviation. ** Assist with the development and execution of Standard Operating Procedures, work flows, work instructions, qualification/validation plans, qualification/validation protocols, summary reports and other technical and non-technical documents for the department. ** Review, edit and route documents for approval. ** Review, track and file of departmental documentation, such as executed software/system development life cycle documents and executed qualification/validation protocols. ** Assist with the development of departmental training curriculum. ** Work with department personnel and the training department to maintain site and corporate training goals. ** Perform a variety of tasks of low to moderate complexity under direct supervision and in accordance with current cGMP standards, with a strong emphasis on acquiring proficiency and learning all aspects of the job. ** Assist department engineers and administrators in qualification/validation activities and in day-to-day support activities as required. ** Perform other tasks of similar nature and level. ** May be required to work in an industrial manufacturing environment including gowning. Basic Qualifications: ** Associate's Degree and 0-1 years of related experience ** Must have a basic understanding of working in a regulated environment ** Experience with the Microsoft Office suite of products ** Experience authoring and reviewing standard operating procedures, on-the-job-training documents, and other controlled documents Preferred Qualifications: ** Bachelor's Degree ** Basic understanding of good engineering, IT and validation practices ** Understand good documentation practices ** Self-motivated with the ability to work in a fast paced environment ** Must have good administrative skills ** Effective interpersonal and communication (verbal and written) skills ** Good organizational skills