Kelly Science, Engineering, Technology & Telecom · 1 day ago
Quality Control Microbiologist
West Chester, OH
Contract
Onsite
Entry, Mid Level
$30/hr - $45/hr
2+ years expKelly Science, Engineering, Technology & Telecom is seeking a Quality Control Microbiologist for a contract role. The Analyst II will support the Quality Control Microbiology department by performing microbiological testing on various sample types in compliance with cGMP requirements.
Staffing & Recruiting
Hiring Manager
Jenney Tidwell
Responsibilities
Read, interpret, and follow SOPs (Standard Operating Procedures) and technical documentation
Author, review, and revise SOPs and work instructions supporting cGMP manufacturing of commercial products
Complete required training and assist with training other personnel as needed
Perform troubleshooting activities related to QC microbiology processes and data
Gather, organize, and communicate operational and quality-related information to cross-functional teams
Participate in and facilitate team meetings to discuss progress, initiatives, and issues
Actively support investigations related to QC processes, including sampling, deviations, and testing impacts
Assist with coordinating activities among internal support groups
Analyze data trends to identify root causes, propose corrective actions, and recommend process improvements
Author and maintain quality records including Deviations, CAPAs, and Change Controls
Identify and implement temporary and permanent solutions to quality or process issues
Escalate issues that fall outside of established SOPs to appropriate leadership
Collect, track, and report metrics related to QC microbiology operations
Monitor equipment and systems for performance and potential issues
Perform gowning and wear sterile garments and PPE as required
Serve as a subject matter expert (SME) within assigned systems or processes
Perform logbook reviews to ensure data integrity and compliance
Lead or participate in continuous improvement and process optimization initiatives
Utilize systems such as MAXIMO and/or other CMMS tools to support equipment and maintenance coordination
Support regulatory inspections and audits, including interactions with regulatory agencies when required
Coordinate qualification and validation-related activities
Perform routine sampling of facility utilities (e.g., water, gases)
Recommend compliance solutions and risk mitigations to management
Participate in interdepartmental meetings to support cross-functional coordination
Qualification
Required
Bachelor's degree in Biology, Microbiology, or a related scientific discipline
Minimum of 2 years of laboratory experience in the pharmaceutical or biotechnology industry
Prior experience supporting microbiological testing in a sterile manufacturing environment
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Linda Stuit
Senior Vice President, Engineering Specialty
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