Tech Clinical Supplies Packaging
This position translates clinical supplies packaging documentation and/or oral packaging descriptions into Master Batch Records, Batch Production Records, and packaging diagrams. The complexity of clinical trial packages and the packaging process require an explicit means of communication, such as diagramming or the use of digital photographs to precisely define the package structure and facilitate the production process. This position will organize operational feasibility meetings and will serve as an integral part of the clinical packaging processes.
Knowledge of GMP regulations, preparation, and coordination of clinical labeling and pharmaceutical packaging documentation, CGMP’s pertaining to clinical supplies or equivalent experience. Must be detailed oriented with very good written communication and computer skills (MS Word, Excel, Visio, Outlook). Experience with planning software such as MS Project, material flow management tools and Materials Requirements Planning (MRP), flow diagramming software and inventory systems.
Ability to run and structure improvement initiative projects applying the methodology and undertaking improvement activities in a systematic way that focuses on enhancing value for the customer by improving the process flow.
The individual in this position must be creative, focused, detail-oriented, team-oriented, hands-on, customer-driven, and capable of functioning in a high-pressure, schedule-driven environment that requires accuracy. Must possess strong problem-solving skills using creative and innovative thinking. Excellent organizational, written and oral communication skills.
- High School Diploma/GED
- Minimum of 2 or 3 years Experience in the pharmaceutical industry.
- BS/BA degree preferred
MAJOR DUTIES & RESPONSIBILITIES:
- Contribute to maintaining packaging production schedule of the Clinical Supplies Great Valley Site, by delivering Batch records on time while maintaining accuracy on all Batch Records and system entries.
- Define and develop packaging instructions with clinical Labeling and Packaging managers in accordance with GMP regulations.
- Translate Clinical Supplies Packaging documentation and or oral packaging descriptions into Master Batch Records and packaging diagrams.
- Liaise with packaging instructions supervisor, Clinical Supplies Packaging Manager (CSPM). The Packaging Operations Manager, Equipment Mechanics and Packaging and Labeling Technicians for the purpose of creating study data in NASCA Inventory Management System.
- Create precise study data in NASCA Inventory Management System.
- Ensure Clinical Packaging documentation complies with GMP Regulations, country requirements, and Standard Operation Procedures.
- Facilitate the packaging production process and schedules by serving as an integral part of the GV clinical supplies flow, delivering accurate and on-time Batch Production Records to ensure product availability for worldwide distribution.
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.
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