Compliance Specialist Senior – Genzyme – Northborough, MA, USA
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.
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.
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, religion, sex, national origin, disability or protected veteran status, or any other characteristics protected by applicable law.
The Quality Systems department manages Change Control, Document Control, CAPA, Product Quality Reviews, Product Complaints, Audits, PPR, Quality Oversight, and Continuous Improvement activities.
Compliance Specialist Senior supports the function of Packaging and Labeling, Facilities, Logistics, Engineering and Validation. Compliance Specialist Senior is responsible for timely and accurate resolutions to deviations, investigations, and corrective actions related to the facility, manufacturing equipment,
metrology instruments, and engineering systems as applicable at gNOC.
The Compliance Specialist Senior is responsible for working with functional groups throughout the site to review and approve deviations, investigations, and corrective actions related to the facility, manufacturing equipment, metrology instruments, and engineering systems as applicable.
The Compliance Specialist Senior will perform a variety of complex tasks under general guidance and in accordance with current GMP’s.
- Providing Quality Review and of deviations related to Equipment, Utility, Facility, Validation and Metrology
- Participating on team to investigate deviations to determine appropriate root cause and CAPAs or may be responsible for CAPA resolution
- Reporting metrics in support of Deviation/CAPA/Effectiveness reviews performed by the department.
- Ability to work independently, with little to no supervision and exercise discretion in determining objectives and approaches to assignments
- Performs in accordance with SOP’s, safety and GMP guidelines to support release of finished product
- Provideguidance and solve issues to resolve and document investigations related to warehouse,
Packaging and labeling, facility and QCRM issues.
- Resolves non-routine problems with minimal guidance or by utilizing the appropriate resources.
- Maintain and increase scientific, regulatory and compliance expertise and work with existing QA group
to develop organizational and technical capabilities.
- Be current with various regulatory requirements and procedures.
- Perform paperwork review of ensure utility data, chart recorders, cleaning log, and pest control data for accuracy.
- Some weekend and overtime scheduled work hours are required to support operations.
- BS/BA degree in a scientific discipline. A combination of education, training and experience may be considered in lieu of the above stated qualifications.
- 7 years of experience working in a CGMP environment
- Experience working in Quality in a GMP environment
- Experience working in a Quality role supporting production equipment
- Experience with technical writing
- Ability to operate in an environment with strict timelines
- Experience performing work that consistently requires decision making and the exercise of judgment and
discretion in a CGMP environment
- Experience demonstrating written and verbal communication skills
- Experience demonstrating proficiency with Microsoft Office applications
- MS degree in a scientific discipline with 3 to 5 years of experience working in a CGMP environment
- Cold chain distribution experience.
Job : Quality
Primary Location : United States-Massachusetts-Northborough