Quality Control Lead, Microbiology (3rd Shift) in Nashville, Tennessee at August Bioservices
NewJob Function: Manufacturing
August Bioservices
Nashville, Tennessee, 37201, United States
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Job Description
Quality Control Lead, Microbiology (3rd Shift)
Reporting to the Supervisor, Microbiology, the Quality Control Lead operates independently to perform biological assays of raw materials, in-process samples, finished product, and environmental monitoring samples. They will represent microbiology leadership on the third shift to ensure that all testing for in-process, finished product, raw materials and stability samples is completed in a timely manner. They will also coordinate with cross-functional teams to support filling and environmental monitoring activities.
ESSENTIAL DUTIES & RESPONSIBILITIES- Act as a subject matter expert for microbiology and compliance, supporting deviation investigations, CAPA implementation, and technical audits
- Review and approve microbiological testing records for accuracy and adherence to test methods instrument malfunctions, and methodology problems
- Represent the microbiology department on relevant cross-functional teams to help improve processes throughout the facility
- Perform microbiological assays including sterility, endotoxin, bioburden, AET, biological indicator enumeration and growth promotion testing
- Support routine and fill-related environmental, personnel and utility monitoring
- Assist in the development and implementation of training programs that govern general and microbiological specific laboratory practices
- Lead and participate in continuous improvement projects in the laboratory including 5S and inventory management
- Bachelor’s degree (U.S. or foreign equivalent) in Biology or a related field.
- 5-7 years of pharmaceutical experience
- Ability to lead, train and mentor analysts in microbiological assays
- Ability to work in a fast-paced environment with minimal supervision
- Able to work flexible schedules at short notice
- Experience with EMPQs and Aseptic Process Simulations
- Familiarity with QMS systems such as Master Control and BMRAM
- Working knowledge of cGMP, FDA, ICH, USP, and other regional and country specific guidance
- Proficient in Microsoft Word, Excel, Outlook, and PowerPoint
- Prolonged periods sitting at a desk and working on a computer.
- Must be able to lift up to 15 pounds at times
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Job Location
Nashville, Tennessee, 37201, United States
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