The Role
Lead microbiology testing and compliance on third shift, performing sterility, endotoxin, bioburden and related assays; review/approve test records; support environmental and fill monitoring; lead training, investigations, CAPA, audits, and continuous improvement projects.
Summary Generated by Built In
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
QUALIFICATIONS
- Bachelor’s degree (U.S. or foreign equivalent) in Biology or a related field.
- 5-7 years of pharmaceutical experience
KNOWLEDGE, SKILLS, & ABILITIES
- 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
PHYSICAL REQUIREMENTS
- Prolonged periods sitting at a desk and working on a computer.
- Must be able to lift up to 15 pounds at times
Skills Required
- Bachelor's degree in Biology or related field (U.S. or foreign equivalent)
- 5-7 years of pharmaceutical experience
- 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
- Experience with EMPQs and Aseptic Process Simulations
- Familiarity with QMS systems such as MasterControl and BMRAM
- Working knowledge of cGMP, FDA, ICH, USP, and other regional guidance
- Proficient in Microsoft Word, Excel, Outlook, and PowerPoint
- Ability to lead, train and mentor analysts in microbiological assays
- Ability to work in a fast-paced environment with minimal supervision and work flexible schedules at short notice
- Must be able to lift up to 15 pounds
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The Company
What We Do
August Bioservices is a Contract Development and Manufacturing Organization (CDMO) headquartered in Nashville, Tennessee. August Bio offers a full range of pharmaceutical contract development and manufacturing services to pharmaceutical and biotech clients. We focus on sterile injectables, topicals, highly-complex formulations, poorly soluble & highly viscous compounds, Uncommon container sizes & fill volumes and offer aseptic and non-aseptic terminally sterilized filling of vials (liquid and lyophilized), syringes and flexible IV bags.
