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Sanofi Group Aseptic Coach Manager - Vaccine in Swiftwater, Pennsylvania

POSITION OVERVIEW

This role is for an exempt employee working in the Aseptic Compliance Department. Their Bi-weekly pay is based on previous experience and education time. Their responsibilities are, but are not limited to:

Safety:

  • Follows all procedures put into effect to ensure your safety as well as the safety of others. Participates in monthly safety meetings.

  • Reports all safety issues, concerns, incidents and near misses to the team leadership.

  • Actively participates in safety walkthroughs coordinated by the department’s safety team.

  • Provides input for potential safety issues as well as contributing ideas for corrective and preventative actions.

  • Follows effective procedures to ensure the production of a safe and efficacious product.

  • Utilizes +QDCI boards for Safety issues

Quality:

  • Regulatory audit understanding and awareness. Point of contact for aseptic behavior discussions for regulatory and internal inspections.

  • Should be able to get Aseptic Gown Qualified.

  • Point of contact for all training change control and CAPA action items associated with interventions or aseptic technique.

  • Participating in/leading scheduling, project, and staff meetings, providing updates of department activities and project statuses.

  • Designing Department Training Plan, managing execution and monitoring training of operators.

  • Ensuring Inspection Readiness of assigned manufacturing areas.

  • Participating in inspections conducted by external regulators and ensuring success of audits for department.

  • Responsible for on-time completion of investigations, CAPAs for major and critical deviations and QEs.

  • Participating in formal FMEAs and Ras and manage Change Controls.

  • Review and approval of Quality Reports, validation protocols and validation reports.

  • Collaborates with Aseptic Process Management and QA on coaching and feedback initiatives.

Delivery:

  • Ensures coaching and feedback of aseptic technique and behavior is performed across all shifts equally.

  • Ensures quality improvements are balanced to maintain or improve production performance and timing.

  • Responsible for coordination and completion of aseptic checklists for all operators.

  • All other duties as assigned. Adheres to all other company time keeping and attendance policies.

Cost:

  • Executes procedure as documented to avoid deviations.

  • Ensure training methodologies are implemented to improve operator efficiencies and quality behavior.

Involvement:

  • Works to become trained on all assigned training modules.

  • Trains and orients new team members (at any level) as assigned.

  • Participates in and leads team meetings. Understands respect, professionalism and confidentiality.

  • Maintains qualified trainer status.

  • Maintains current understanding of cGMP and industry best practices in regard to aseptic technique and practices and shares with department personnel on a regular basis.

All other duties as assigned.

Requirements

  • Must be very detail-oriented and organized, with excellent time-management and ability to handle multiple priorities and report progress.

  • Strong analytic and problem-solving abilities, as well as the flexibility to change and adapt as the job grows and develops.

  • Excellent verbal and written communication, interpersonal and presentation skills, as well as the ability to interact tactfully and effectively with employees at all levels of the organizational structure.

  • Intermediate to advanced proficiency in MS Office Suite, particularly Word, Excel, and PowerPoint

  • Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or government regulations.

  • Ability to write reports, business correspondence, and procedure manuals.

Education:

  • Bachelor's degree

Experience Required:

  • 3 years of experience with Quality Systems in Pharmaceutical, Medical Device and/or IVD industries

  • Experience in FDA Regulated Industry

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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