Senior Aseptic Manufacturing Specialist
2 days ago
We are seeking a highly skilled Senior Aseptic Manufacturing Specialist to join our team at R&D Partners. The ideal candidate will have a strong background in biopharmaceutical-based GMP manufacturing operations, including experience in cell culture and associated downstream processing.
Key Responsibilities:
- Develop a deep understanding of GMP cell therapy manufacturing processes and execute them with precision.
- Complete training sessions and maintain accurate training documentation.
- Ensure compliance with quality standards and requirements.
- Provide operational support functions, including materials stocking and transfer, kit preparation, reagent preparation, room readiness, cleaning activities, and equipment maintenance.
- Review and verify document accuracy, including executed Batch Records and Logbooks.
Shift Schedule:
- Week 1: Sunday to Tuesday, 6:00PM – 6:30AM
- Week 2: Sunday to Wednesday, 6:00PM – 5:30AM
OR
Shift Schedule:
- Week 1: Wednesday to Saturday, 6:00PM – 5:30AM
- Week 2: Thursday to Saturday, 6:00PM – 6:30AM
Preferred Qualifications:
- Minimum 3 years of experience in biopharmaceutical-based GMP manufacturing operations.
- Excellent visual acuity and color perception.
- Quality mindset and familiarity with 21 CFR Part 11 and standard GxP best practices.
R&D Partners is a national staffing firm focused on scientific, clinical research, and engineering staffing. Our team offers over 200 years of combined staffing experience, providing consulting, direct hire, and outsourcing solutions across the US.
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