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Manager Quality Control Microbiology
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Full-time
- Job DetailsLevel ManagementJob Location ADMA Biologics - Boca Raton, FLPosition Type Full TimeEducation Level 4 Year DegreeJob Category QA - Quality ControlDescription ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection.
- Qualifications Ability to lead the Quality Control microbiology and environmental monitoring team with emphasis on mentoring, guidance, training, and development of staff in a 24/7, fast paced, FDA regulated work environment.
- Strong working knowledge of WFI systems, clean room control and operation, environmental monitoring technologies and trending, aseptic manufacturing concepts, and microbiological testing (sterility, endotoxin, bioburden etc
- Accountable for maintaining area of operation in compliance with cGMP requirements, cUSP requirements (as appropriate), environmental health and safety policies, and all governmental regulatory requirements for the biopharmaceutical and plasma derived blood products industry.
- Provide directional oversight to investigations (deviations, Out-of-Specification, alert and action limit) and ensure effective CAPA implementation for the microbiology laboratory.
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