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Quality Specialist Senior –Genomics Medicine Unit Framingham, MA (L2-1)

Job Description:

• This position will report to the Manager of Quality and will assist in maintaining the quality systems and GMP compliance in support of cell and gene therapy products at Sanofi.

• This is a second shift position 130pm to 10pm Monday through Friday.

• Perform review of Batch records and associated documents in support of release of intermediates.

• Review of Analytical data

• Participate or lead in investigation of all lot-associated deviations, change controls, Environmental Management System (BMS) investigations, action notices and environmental excursions as required.

• Perform QA presence on the floor/person in plant.

• Perform various QMS trending/reporting functions.

• Ensure compliance to the relevant SOP and corporate standards.

• Lead/Participate in investigation of non-lot associated deviations, change controls (CCR/LCR), Building

• Participate in walkthrough program.

• Manage assigned site QA projects.

• Ensure that documentation and operations meet established requirements of cGMPs, Internal SOPs and company policies. Draft and revise procedures (DCR) as required.

• Serve as an internal auditor for the site.

• Actively participate in the preparation, execution and follow-up for audits from Global Quality Auditors.

• Participate or facilitate FMEA/Risk as appropriate.

• May serve as team leader for continuous improvement teams or investigative teams.

• Investigate quality critical alarms.

• Assist in the development of Quality Technical Agreements (QTA).

• Performs work that requires decision making and the consistent exercise of independent judgment and discretion.

• Perform Quality Assurance review for deviations, investigations, DCRs and complaints and manage associated files.

• Review and approve Validation protocols and technical reports as appropriate.

• Assist in the oversight of the sterility assurance program.

• Perform, External audits.

Education

• Master's Degree & 3 years of experience OR bachelor's degree & 5 years of experience in cGMP.

• Ideally the candidate will have a bachelor’s degree in microbiology.

Preferred Qualifications:

• Excellent communications skills both written and verbal.

• Strong knowledge in aseptic technique, practices and theory.

• Strong Knowledge of Contamination Control

• Experience in Cell and Gene Therapy

• Strong critical thinking ability. Strong leadership ability.

• Effective time management and organizational skills.

• Strong attention to detail and ability to lead others in a team setting.

• Experience with CDMOs.

• Special Working Conditions.

• Ability to gown and enter clean rooms.

• Ability to perform visual inspection for final product.

• May require up to 15% of travel (Domestic and international).

Sanofi Inc. 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.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.