Quality Control Microbiologist

Analyst II – QC Microbiology (Contract)

Location: West Chester, OH

Employment Type: Contract

Estimated Pay Rate: $30–$45 per hour (based on experience and qualifications)

Position Summary

The Analyst II, QC Microbiology contract role supports a Quality Control Microbiology department by performing quality-related activities for pharmaceutical products. Responsibilities include documenting and executing microbiological testing on a variety of sample types such as raw materials, in-process and finished products, stability samples, water, gas, and environmental samples, in compliance with cGMP requirements.

Key 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.

Qualifications

• 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.