Quality Professional Specialist, Allston, MA - NTO Rotation 12Hrs Shift- 7PM-7AM

Rotating 12 hour NIGHT SHIFT position- 6:45PM-7:15AM
Quality Assurance (QA) is responsible for quality oversight of operations at Sanofi Genzyme Allston Landing facility, a large scale therapeutic protein manufacturing facility. The main role of QA within the organization is to provide an independent oversight of operations, inclusive of the production areas and Quality Control laboratories, to ensure that CGMPS are maintained and quality product is manufactured. In order to achieve this QA reviews and approves Batch Records, Deviations, Laboratory Investigations, CAPAs, Change Controls Requests, Document Change Requests, effectiveness reviews as well as associated documentation in support of Preventive/Corrective Maintenance, Metrology, Automation Engineering, Validation and dispositions intermediates and Drug Substance, and provides QA on the floor presence. QA has the following mission: Patients lives drive our company; it is our mission to ensure the Quality of our products, provide mentorship in a dynamic environment of teamwork and have the courage to daily engage the highest values of accountability and integrity as patients are our focus and commitment as a Quality team. This mission is underpinned by the following core values: Courage, Accountability, Integrity, Teamwork and Mentorship.
Position Overview with Key Responsibilities Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs. Demonstrate 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 of our products and services. This includes: Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures. Acting with integrity and treating people with respect and courtesy. Constantly striving to make Sanofi Genzyme a great place to work, and a company respected for the quality of its people and products. This position is responsible for performing a variety of complex tasks under general guidance and in accordance with current GMP's. The responsibilities include but are not limited to: Operations Responsibilities: Perform record issuance and record review to ensure the compliance of manufacturing procedures to in-house specifications and government regulations on the manufacturing floor and ensuring on-the-floor presence of QA. Conduct review of manufacturing processes to ensure compliance. Conduct review of testing results in support of release of intermediates. Provide compliance guidance to other support teams. Lot/ Intermediate Disposition Responsibilities: Participate in bulk shipment oversight activities. Participate in Quality release activities of manufactured intermediates. Deviation/CAPA Management Responsibilities: Work closely with manufacturing and support groups to resolve all deviations within agreed timelines. Perform deviation investigation activities, including; GEMBA, containment, classification and initial impact assessment. Support root cause analysis for deviations related to equipment, utilities, facilities, metrology and validation. Assist in deviation/nonconformance identification and resolution. May act as team member to investigate deviations to determine appropriate root cause and CAPAs.
Quality Engineering Responsibilities: Work with functional groups across the site to review and approve quality and technical documentation including: deviations, CAPAs, Action Notice (AN), Change Control Requests (CCR), Documentation Change Requests (DCR), effectiveness reviews as well as associated documentation in support of Preventive/Corrective Maintenance, Metrology, Automation Engineering and Validation. Review unscheduled maintenance and facility alarms, specifically the return to service testing and assessing potential impact to product. May provide support for visual inspections of vessel surfaces, when required. Assist in the development of robust maintenance procedures. Additional Responsibilities: Participant in internal audits. Participant in Lean initiatives to improve Quality processes. Participant in QA audit readiness program as well as assist and participant in external audits and regulatory inspections. Participate in the QA consistency meetings to drive continuous improvement efforts. Support the QA on the floor initiatives which includes; attending daily MDI meetings and assisting customers with resolution of issues in real time. May provide training to new employees. Effectively interact on a cross functional basis providing QA guidance at the area level and escalate any issues to Management in a timely fashion. Ensure that department goals are achieved and on time Quality product is realized through execution of primary role in area of oversight (Batch Record Review, Deviation Management and/or Lot Disposition, etc.). Comply with the requirements of Sanofi Genzyme's health and safety program.
Basic Qualifications:
Bachelor's Degree and 3 years of experience, or Associate's degree and 5 years of experience, or 5 years of experience in the BioTech / Pharmaceutical Industry or equivalent. Minimum 1 year experience within Quality Control, Manufacturing, or equivalent role
Preferred Qualifications:
Knowledgeable in CGMP, ICH, EMA and FDA rules, guidance and expectations. Experience in on the job training and authoring SOPs. Strong computer, verbal and written communication skills. Strong technical writing skills
Special Working Conditions:
Ability to gown and enter clean rooms. Requires extended time in manufacturing areas.
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.

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