Manufacturing Operations Specialist
1 month ago
We are seeking a highly skilled Manufacturing Operations Specialist to join our team at Randstad Life Sciences. As a key member of our external manufacturing network, you will be responsible for providing critical information and data analysis to drive performance execution across our global operations.
The ideal candidate will have a strong background in manufacturing processes, particularly in upstream drug substance, and experience working with external parties and leading cross-functional teams. You will be responsible for ensuring accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting, as well as owning NC Class II/III records, CAPA, CAPA EV, and more complex change control records.
Key Responsibilities:
- Manufacturing operations: Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting.
- Site performance monitoring: Report contract site performance metrics to site lead and identify improvement opportunities for site performance.
- Project Management and Technology transfers: Follow-up and track activities in a department-wide project from conception to implementation and close-out.
Requirements:
- Bachelor's in Science, Engineering or related field.
- 5+ years of experience in protein, API, DS, DP, or packaging manufacturing environment.
- 5+ years in roles requiring knowledge of cGMP principles, FDA and other regulatory guidelines, and validation principles.
- 2+ years of project management experience leading multi-functional and/or multi-location team.
- 1+ years of experience working with external parties and/or leading cross-functional teams for clinical and/or commercial products.
What We Offer:
- A great company doing groundbreaking and important work with a great reputation in the industry.
- A collaborative and dynamic work environment.
- Opportunities for professional growth and development.
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