**2nd shift position- 2pm-10:30pm- schedule includes weekends and might be rotating based on needs of department. Overtime as per business needs**
**This department is/supports Biological Services**
Performs production activities in accordance with volume fluctuation, business need, and effective procedures. Works to support production units by consistently providing required materials in a timely manner. Ensures all materials required for production are available prior to need. Identifies production issues and relays them to the leadership team. Ensures all required paperwork is complete, accurate and done in a timely manner to ensure accurate inventory. Completes tasks and corresponding documentation as required by cGMP. Works to prepare assigned areas for the oncoming shifts.
Completes at least one developmental class annually focused on one of the four core competencies. Works to become trained in all assigned training modules. Trains and orients new team members (at any level) as assigned.
Follows all procedures put into effect to ensure your safety as well as the safety of others. Participates in monthly safety meetings. Report 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. Works to understand cGMP’s. Identifies areas of deficiency to the leadership team and offers potential suggestions for improvements. Participates in both deviation investigations when appropriate and implementation plans to ensure a quality product. May participate in completion of quality documentation (BPR's, logbooks, etc.).FDA audit understanding and awareness.
Participates in team meetings. Actively communicates improvement ideas, issues, concerns, etc. to team. Participates in cross functional teams where necessary to complete projects in an effective and timely manner.
Lead Operator, Completes picklists and move tickets for all tasks completed on any given day. This may require inputting data into SAP, along with entering work orders and reagent orders. Ensures proper process area operation by pre and post run set up and maintenance of lab and equipment. Recommends changes to BPRs, SOPS and SWIs were warranted. Write and edit documents under supervision. Seeks out cross training in other areas whenever possible. Responsible for assisting in writing and assisting incident investigations, CAPA's, change controls, along with assisting the higher tech levels and Principal Investigators with projects. All other duties as assigned.
HS equivalent and 2+ years in cGMP or Pharmaceutical experience
Associates with 1 + years in cGMP or Pharmaceutical experience
Bachelors with 0 + years in cGMP or Pharmaceutical experience
Prior or related cGMP or Pharmaceutical experience recommended
Must have basic mechanical aptitude, computer skills, good comprehension skills, retention skills, manual dexterity, and ability to troubleshoot.
The Company believes that facilitating cross-functional development of its employees is extremely important. While posting a job internally does not guarantee that an internal candidate will be selected for the position, it does bring transparency to the hiring process and allows interested employees to inquire about or apply for the position.
Employees are encouraged to pursue their career interests within their own departments and also to consider opportunities in other departments. Employees are encouraged to consider opportunities in different department where they can utilize their transferable skills. The Company supports its hiring managers sourcing and considering qualified employees for open requisitions. The Company equally supports managers who consider the long-term needs of the organization and of its employees by fostering internal talent movement. In this way, the Company can help retain and develop its most valuable resource, its people.
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.