Sanofi Group Training and Compliance Specialist in Framingham, Massachusetts
Training and Compliance Specialist
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.
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.
Job Responsibilities/Department Description:
We are seeking a Training& Compliance Specialist to join a dynamic, motivated team of scientists and compliance personnel dedicated to product development, support and manufacturing in a GMP compliant environment. As a Training & Compliance Specialist youmanage the Quality System Training Program of the Clinical Trial Manufacturing (CTM) site; performing process development and GMP manufacture of Phase I/II biologic bulk drug substances and sterile finished drug products. The core responsibility is the day-to-day management of the training tracking system, as well as serving as a primary compliance resource for GMP personnel managing their training in conjunction with their Supervisor/Manager. The Training& ComplianceSpecialist will interact with individuals at multiple levels within all functional groups of CTM.
Manage Sanofi Training Systems, ensuring GMP personnel are appropriately and adequately trained to perform their assigned function to a high level of competence, regulatory compliance and efficiency.
Act as the Training System ‘expert’ for all day-to-day issues concerning Training and Development products and services by providing technical expertise and operational support.
Provide strategic oversight of the training program and system.
Work directly with all levels and departments of CTM to establish training curriculums and assignments based on assigned functions.
Process and maintain file system for training records
Assign Computer Based Training modules and track completion
Ensure critical procedures have appropriate mechanisms to demonstrate comprehension and understanding, such as “On the Job Training”, quizzes or qualifications. The Training Coordinator will work with applicable functions to assist in development of quizzes and qualifications.
Maintain system to track required training and qualifications
Ensure the timely and accurate retrieval of personnel training and qualifications.
Liaison with Document Control and other functional departments to coordinate training on new or revised procedures.
Evaluate, develop and implement improvements to current training tracking system.
Assist with the generation and/or revision of GMP documentation such as standard operating procedures.
Assist with performing internal audits
Work closely with Manufacturing, Facilities and Quality Control staff to resolve quality/complianceissues
Continually evaluate systems and procedures for improvement for efficiency while ensuring compliance to applicable regulatory requirements and standards
Other duties as assigned
Bachelor's degree (BS/BA) with 2-4 years industry experience in quality operations including experience in cGMP, pharmaceutical / biopharmaceuticals environment.
Experience within the biologic, pharmaceutical or medical device industry with responsibilities for developing or delivering training to colleagues and/or managing a training program.
Familiarity with current Good Manufacturing Practices (cGMPs) and 21 CFR 210/211
Familiarity with electronic systems, including Microsoft Access and Excel
Strong verbal and written communications, effective time management, and organizational skills are essential to success in this role.
Must be independent, detailed oriented, have the ability to manage own time, be flexible, and team oriented, balancing as appropriate
Understanding of biological manufacturing processes of cell culture upstream/downstream Bulk Drug Substance production or Aseptic Filling a plus.
Familiarity with aseptic gowning practices and aseptic techniques a plus.
Ability to quickly learn and navigate new electronic systems
Ability to comfortably speak in front of audiences
Able to work in a team setting and independently under minimum supervision
Ability to work in fast paced environment supporting the quality assurance/quality control departments of Phase I/II GMP manufacturing of biologic bulk drug substance and sterile finished drug product.
Creative individual with excellent trouble shooting skills
Requires the ability to produce results in a fast-paced environment to meet clinic deadlines
Primary Location: United States-Massachusetts-Framingham
Job Posting: Aug 30, 2016, 7:39:14 AM
Job Type: Regular
Employee Status: Regular