What are the responsibilities and job description for the Quality Assurance Specialist position at Sanofi?
Quality Assurance Specialist Gene Therapy, Framingham, MA
This position will report to the Quality Manager and will assist in maintaining the quality systems and GMP compliance in support of gene therapy products at Sanofi. This is a second shift position 130pm to 10pm Monday through Friday.
Duties will include but not be limited to:
Perform review of Batch records and associated documents in support of release of intermediates
Perform QA presence on the floor/person in plant
Perform various QMS trending/reporting functions.
Ensure compliance to the relevant SOP and corporate standards.
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.
Investigate quality critical alarms.
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.
Assist in the oversight of the sterility assurance program.
Perform, External audits
Second shift work may be required.
Gowning
Requirements
Education/Experience
Bachelor's Degree & 1-3years of experience in cGMP.
Basic Qualifications
Excellent communications skills both written and verbal.
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 10% 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.
Salary : $72,900 - $92,300
