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Sanofi Group Compliance Specialist in Ridgefield, New Jersey

JOB TITLE: Quality Assurance Compliance Specialist

SUMMARY:

The Quality Assurance Compliance Specialist is dedicated to managing the Quality Compliance on the Shop Floor audit program, the Aseptic Process Simulation (Media Fill) observation program, and the Critical Alarm Reconciliation Program. The role of the Quality Assurance Compliance Specialist will be that of a Subject Matter Expert as related to Microbiology, Aseptic Practices, Environmental Monitoring for Controlled Facilitates, leading and participating in site contamination control and process utility investigations and escalating matters, directly related to aseptic manufacturing and contamination control, to upper management. Additional support shall be provided to the Contamination Control Program in relation to environmental monitoring and process utility trending.

JOB RESPONSIBILITIES:

The Quality Assurance Compliance Specialist is part of the Quality Assurance Department at Ridgefield, NJ. This role is responsible for providing information and feedback to the area and upper management whose objectives are to ensure cGMP are maintained and the site remains in a state of a continued process and environmental control and to:

  • Independently perform Quality Assurance walkthroughs of classified manufacturing areas to observe and evaluate production activities, aseptic processes, and the proper execution of Batch Production steps.

  • Identify any deficiencies and provide proper notification to area management.

  • Prepare Quality Assurance walkthrough summary reports detailing the walkthrough findings and identify any follow-up items that require escalation to Area Management.

  • Perform trending of all environmental monitoring and process utility data.

  • Review the trends and escalate any issues to Senior Management.

  • Calculate Contamination Recovery Rates (CRRs) for all Graded Manufacturing areas and personnel and recommend CAPAs for continual improvement.

  • Prepare and present quarterly environmental and process utility trend report.

  • Participate in the Environmental Action Committee (EAC) and routine EAC meetings.

  • Review environmental monitoring and process utility data and trend reports, CAPA remediation for effectiveness, project plans, walkthrough findings, and other issues related to environmental control systems.

  • Escalate critical issues and adverse trends to Senior Management and recommend CAPAs.

  • Lead the Aseptic Process Simulation (Media Fill) observation program. Ensure the program continues to comply with corporate and regulatory requirements.

  • Maintain and manage a team for media fill observations. Escalate finding to Management as required.

  • Lead the Alarm Reconciliation Program ensuring all facility Critical alarms generated are accounted for and proper root cause, corrective action, and event assessment are complete and accurate.

  • Present any data and findings at monthly EAC meetings.

  • Update Quality Assurance standard operating procedures as required

  • Perform Gap assessments of corporate standards and guidance documents where required.

  • Participate in programs for process improvements when required.

  • Provide Quality Assurance and Microbiological knowledge to facility improvement projects as required.

LEAD COMPETENCIES:

The Quality Assurance Compliance Specialist is expected to act on and demonstrate the Sanofi LEAD competencies:

Act for Change

  • Continue to look for and implement improvement opportunities and best practices via QA Walkthroughs, Aseptic Process Simulation Observations, and through gap analysis/review of current methods and practices versus corporate standards.

Strive for results

  • Continue to be responsible for the Media Fill Observation schedule and address any issues noted during the Media Fill process.

  • Continue to perform trending and author reports.

Cooperate Transversally

  • Continue to communicate and work with different departments to ensure site compliance and meet site goals.

  • Participate in meetings and investigations (Change Control, Risk Analysis, Deviations, etc.) as Contamination Control / Compliance Specialist SME as required.

Commit to Customers

  • Continue to support all internal and external audits.

  • Commit to customers by working with all groups on site including but not limited to validation, facilities, engineering, QA, and QC to ensure compliance.

Think Strategically

  • Continue to review applicable corporate standards, pharmacopeia updates, and regulatory updates to ensure facility compliance.

  • Identify compliance issues through QA walkthrough inspections, gap analysis, and internal audits and be involved in strategic remediation planning.

Lead Teams

  • Continue to lead the Media Fill Observation team and manage the observation schedule and address any issues noted.

Make Decisions

  • Continue to inform management of critical compliance and quality decisions and escalate issues when required.

JOB REQUIREMENTS:

Education & Experience

  • Bachelor’s degree, or equivalent, in a science field (Biology / Microbiology preferred)

  • 5 years of Quality Control Microbiology or Quality Assurance experience in a cGMP manufacturing environment.

  • Microbiology knowledge

  • Aseptic Technique and Aseptic Gowning knowledge

  • Strong technical writing skills

  • Ability to communicate clearly and effectively both orally and in writing

  • Time management, attention to detail, organization, teamwork, and collaboration skills.

  • Ability to work independently

  • Ability to interact and present information to upper-level management

  • Working knowledge of Word, Excel, and PowerPoint

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As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

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.

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