Location
Framingham, MA | United States
Job description
8 NYA is an integrated, continuous, biomanufacturing facility (ICBF). The facility is operated by upstream, downstream and support services groups which support a 24/7 large-scale therapeutic protein manufacturing facility housing multiple products.
This Suite Coordinator position is responsible for a diverse range of manufacturing related activities during plant start-up from Operational Commissioning/Shakedown through process validation (PV) and commercial operations.
The Suite Coordinator will be responsible for performing a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set and current GMPs.
Core Responsibilities
Create and coordinate training activities and track progress through glidepaths
Maintain and update training road maps training matrix
Works with Compliance Specialists to create and close out CAPA’s
Document Change Requests (DCR’s, EDD’s)
Participates in cross functional projects and performs SME assessments for CCR’s
Redundant Manufacturing reviewer of SOP’s, EWI’s, EBR’s and EUR’s
Performs routine documentation assessments to ensure alignment between SOP’s/EBR’s/EUR’s
Co-ordinates with MLC’s to ensure adequate stocking of the area
Partners with supply chain to ensure adequate SUT for operations
Partners with MFG Supervisor’s to complete audit readiness walkthroughs Coordinates with the scheduling team and schedules non-routine activities with support areas
PMs, Calibrations, action notices
Works with the scheduling team to report schedule adherence
Provides input and recommendations on how to accomplish objectives with schedule changes and/or business needs
Ensures timely issue escalation to manufacturing leadership and cross functional support teams
Demonstrates flexibility, responsiveness, and teamwork in response to changing schedules and needs of the business
Continuous Improvement
Contributes to continual improvement of all manufacturing documentation (SOP’s, EWI’s, MBR’s, OJT’s) to ensure they are current, accurate, and clear.
Manages or supports plant floor continuous improvement initiatives
Represents Manufacturing in Project Team meetings; may lead department initiatives and projects
*Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.
Leadership Qualification:
Able to work with and lead cross functional teams through complicated processes in a Quality system
Capable of effective and clear communication that enables teams to execute on key deliverables.
Basic Qualifications:
Bachelor’s degree with greater than 5-8 years of cGMP experience
Strong understanding of cGMP manufacturing
Demonstrated ability to effectively coach and train employees
Preferred Qualification:
Training, coaching, leadership experience
Experienced facilitating meetings
Experienced reviewing electronic batch records, electronic work instructions, on-the-job-trainings, and other controlled documents
Experienced in troubleshooting, investigation, and root cause analysis in a cGMP environment
Special Working Condition:
Ability to lift up to 50 lbs
Ability to stand on average 6 hours per shift
Ability to gown and gain entry to 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.
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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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