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Full lifecycle review and disposition of parenteral manufacturing Batch Records (Formulation, Filling, Inspection, & Packaging) for Media Fills and Drug Product. Provide training to all QA Associates and Specialists on surveillance oversight and on-the-floor Batch Record review requirements.
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Working closely with the QA Manager, the Senior QA Specialist will be instrumental in supporting major QA programs. Senior QA Specialist - Batch Review. The ideal candidate will a Bachelor’s Degree in Chemistry, Biology, Biochemistry, Microbiology or related discipline.
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Typical processes being developed / validated include mixing, filling, formulation, visual inspection and lyophilization. 5-7 years in Process Validation (formulation, filling, visual inspection and/or lyophilization.
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Operate all formulation, sterile filling, inspection and final vial packaging equipment. Perform manual inspection of empty vials and filled product with a focus on quality and efficiency.
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The organization consists of operational teams for Filling, Formulation, wash and sterilization, as well as inspection and support. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe.
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Formulation, filling, labeling, capping, packaging and visual inspection of vaccines. Assist with performing aseptic procedures including product formulation, fill equipment setup and operations, and environmental monitoring.
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If you ever wanted to have a direct impact building a team’s culture and in how the team operates, now is the perfect opportunity During the project phase, the Parenteral (PAR) Operators (Entry to Expert roles) will support start up activities required to bring the area into service which may include formulation, aseptic isolator barrier filling, and visual inspection.
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Assigned process(es) inclusive of clinical and commercial operations of aseptic filling, formulation, equipment preparation, sanitization, visual inspection, analytical testing and/or single use systems.
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Technical understanding of Drug Product (DP) manufacturing operations, such as buffer batching, DP formulation, DP Filling, Inspection. Technical understanding of Drug Product (DP) manufacturing operations, such as buffer batching, DP formulation, DP Filling, Inspection.
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As a Production Supervisor, you will play a pivotal role in overseeing various production areas including formulation, aseptic filling, inspection, and labeling/packaging. As a Production Supervisor, you will play a pivotal role in overseeing various production areas including formulation, aseptic filling, inspection, and labeling/packaging.
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This facility performs secondary vaccines manufacturing processes including: Formulation, Filling, Lyophilization, Visual Inspection, and Leak Detection. This facility performs secondary vaccines manufacturing processes including: Formulation, Filling, Lyophilization, Visual Inspection, and Leak Detection.
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Work on and potentially lead efforts to establish new programs to support Drug Product facility including start-up of formulation, filling, inspection, assembly, and pack and label team.
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Supporting all aspects of Production for sterile drug products, overseeing Production Technicians and performing technician duties such as batch kitting, formulation, aseptic filling, inspection and labeling.
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Owning or supporting investigations related to material transfer, API production, drug substance formulation, drug product filling, inspection, and packaging. Orano Med is seeking a Production Lead to support the production of commercial radiopharmaceutical products at the ATLab Indianapolis site.
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Author Batch Records and Specification sheets for Formulation, Filling, Inspection and Finishing. Associates degree in a scientific discipline and 10+ years' experience in a pharma industry, formulation and aseptic manufacturing experience required.
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