type de contrat
reférence de l’emploi
**Monday-Friday- 8am-5pm with flexibility**
**Looking for individuals with prior exposure/experience to deviation, technical writing, and preventative and corrective action experience**
Job Description Summary Department Description:
The Manufacturing Operations is comprised of teams responsible for leading quality investigations and driving corporate quality system implementation through consent decree remediation across all manufacturing departments in support of 24/7 large-scale therapeutic protein manufacturing. The departments' responsibility is to lead deviation investigations including formal root cause assessments and implement, maintain, and continuously improve manufacturing's quality systems. The department will also develop new and/or revise manufacturing practices, Standard Operating Procedure (SOP) and Production Records for manufacturing operations through consent decree remediation.
The Manufacturing Specialist uses expert knowledge of compliance and CGMP manufacturing processes to manage and own all process related documents, to include investigations and improvement initiatives within upstream operations.
- Displaying subject matter expert knowledge in the manufacturing processess.
- Utilizing documentation control systems to author, review, and improve documentation
- Utilizing deviation management systems to document, investigate, and closeout deviation events
- Utilizing strong understanding of compliance and CGMP to manage cross functional teams to drive investigation close out, determination of root cause and implementation of appropriate Corrective and Preventative actions
- Utilizing process knowledge and investigation skill sets to identify and rectify departmental issues
- Participating in and leading cross-functional teams to effect change
- Developing Manufacturing training curricula and working with Manufacturing Supervisors and Quality Training group to develop and ensure consistency in training materials through the on-the-job training program on process operations, theory, and compliance.
- Effectively demonstrates an understanding of CGMPs & how it applies to specific responsibilities.
- Following accurate oral & written procedures in operating production equipment & performing processing steps
- Practices safe work habits and adheres to Sanofi Genzyme’s safety procedures and guidelines. Trains new employees.
- Collaborates with QA, QC, MTS, and Manufacturing Engineering to affect change in process, procedures and work practices.
- Utilize manufacturing knowledge to improve process operations and affect positive change.
- Works independently with minimal supervision and direction. Participates in determining objectives of assignment. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion
- Bachelor’s or Associate’s Degree with 5-7 years in CGMP manufacturing environment
- SME in Preparation, Cell Culture and Purification operations
- 1 year experience with deviation or investigation management systems
- Training, coaching, leadership experience.
- Experienced leading and influencing cross-functional teams
- Experienced facilitating meetings
- Experienced authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents
- Familiarity with deviation management systems (i.e. Trackwise).
- Experience in troubleshooting, investigation, and root cause analysis in a current good manufacturing practices (CGMP) environment.
Special working conditions are specific requirements that an individual needs to perform the job requirements (e.g., 10% international travel; ability to gown and enter clean rooms).
Ability to gown and enter clean rooms.
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.