Sanofi Group Senior Quality Assurance and Compliance Specialist - Nights - 12hrs rotation in Framingham, Massachusetts
The Quality Assurance (QA) Operations is responsible for quality oversight of operations at Sanofi's Framingham Biologics facilities. QA's main responsibility is to ensure cGMPs are adhered to during manufacturing operations. Quality Assurance Operations is responsible for providing support and guidance to the Sanofi Operations function in order to protect the safety, quality and efficacy of Sanofi's Products, thereby ensuring the availability of compliant and safe products for our patients and assuring the security of the company's business and global markets.
The Senior Quality Assurance and Compliance Specialist is responsible for providing quality support and guidance to manufacturing and support functions to ensure continued compliance to cGMP. The Senior Quality Assurance and Compliance Specialist is also responsible for mentoring and supporting the junior staff.
Provide Gemba Support.
Perform batch record review.
Perform review of column packing and qualification records.
Function as SME on input related to quality decisions.
Approve Non-conforming material discards.
Perform log book review.
Provide on the floor (OTF) support to the operations department, including OTF support for critical operations steps.
Issue action notices and conduct affiliated provisional release.
Conduct log book audits against compliance requirements.
Review Cleaning Verification (CV) related documentation against specification.
Perform media / buffer and intermediate release.
Prepare Bioreactor summary.
Support internal audit preparation activities as well as cross-functional internal audit activities and conduct walkthrough inspections.
Execute containment activities.
Provide off-hour support for batch record and log book issuance.
Partner with manufacturing and support operations to ensure a culture of continuous compliance.
May provide training to new employees.
Revise procedures / SOPs.
Initiate and Investigate and QA review deviations.
Perform Bulk Gas release.
Review NRSR (Non Routine Sample Requests).
Other activities as assigned.
Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.
An ongoing commitment to conducting our global business according to the highest legal and ethical standards and to continually pursue excellence in the development and delivery of all our products and services.
Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.
Being honest and treating people with respect and courtesy.
Constantly striving to make Sanofi a great place to work and a company respected for the quality of its people and products.
Acting as role models for our fellow employees by acting responsibly, fairly and honestly in our dealings and exercising sound judgment in performing our jobs.
Bachelor’s Degree in a scientific field and 4 years of related experience, Associate's Degree and 6 years of related experience or High School Diploma and 8 years of related experience in a Quality and /or other CGMP related field.
Bachelor’s degree in a non-scientific field with 6 years of related experience in a Quality and / or cGMP environment.
Basic to Intermediate computer proficiency, strong verbal and written communication skills.
Experience with quality systems and cGMP data review.
Bachelor’s degree in a scientific field with 4 years of experience in a Quality and / or cGMP environment.
Experience in bio-pharmaceutical industry.
Strong technical writing skills
Effective time management, attention to detail, organizational skills, teamwork and collaborations.
Demonstrated competence in problem solving methodology.
Experience participating and/or leading cross-functional project team collaborations.
Special Working Conditions:
Ability to gown and gain entry to manufacturing areas.
Ability to work a 12-hour rotating shift and every other weekend, including some holidays.
Ability to lift 10 lbs.
Above information was designed to indicate the general nature and level of work performed by employees with this job description. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.
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.
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.