Microbiology Analyst
The Microbiology Analyst at Confidential Client is responsible for performing routine microbiological sampling, testing, and environmental monitoring to ensure pharmaceutical products meet stringent quality and regulatory standards. This entry-level, full-time role requires adherence to FDA and USP guidelines within a fast-paced, FDA-regulated environment, emphasizing compliance, troubleshooting, and continuous improvement in microbiology laboratory operations.
About Careertakes
👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Scientific & QA.
Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.
What You’ll Do
This entry-level QC Microbiology Analyst role supports pharmaceutical manufacturing by performing routine microbiological sampling, testing, environmental monitoring, and lab maintenance in a regulated GMP environment. You will help detect and identify microbial contaminants to ensure product quality and regulatory compliance.
- Models professional conduct and follows company code of conduct
- Perform routine sampling of utilities and environmental monitoring (EM)
- Conduct environmental monitoring of cleanrooms and controlled areas (viable/non-viable particulates, surface sampling, personnel monitoring)
- Perform routine microbiological testing (e.g., water systems bioburden, endotoxin) and maintain microbial cultures and media
- Prepare and qualify media; assist with microbial identifications
- Ensure laboratory equipment is compliant with procedures and GLP/GMP prior to use
- Perform GMP review of test data and document results per procedures
- Troubleshoot basic laboratory and instrumentation issues and recommend corrective actions
- Maintain inventory of QC laboratory supplies; coordinate replenishment to avoid expiry
- Participate in cleaning, inventory, maintenance, and continuous improvement activities (SOP/WI updates, OJTs)
- Support audit readiness: prepare lab areas for internal and external audits and assist in self-audits
- Communicate status, progress, and roadblocks; collaborate with stakeholders across departments
- Use appropriate PPE and follow EHS procedures for safe handling and work in gowning/aseptic environments
Who You Are / Qualifications
- Bachelor’s degree in Microbiology, Biology, or related life science preferred
- 0–2 years of related experience; entry-level candidates with strong laboratory fundamentals are encouraged
- Understanding of aseptic technique and microbiological test methods
- Familiarity with regulatory guidelines (e.g., FDA 21 CFR, USP <61>, <62>, <85>, <1116>, EU Annex 1)
- Ability to read, author, redline, and execute SOPs and WIs
- Strong organizational skills and ability to prioritize and manage multiple tasks independently
- Good written and verbal communication and technical writing skills
- Analytical mindset with problem-solving and troubleshooting abilities
- Able to lift up to 30 lbs and work in varying incubator temperature/humidity conditions
- Comfortable working in cleanroom gowning and aseptic environments
Schedule & Location
- 100% on-site at the Confidential Client facility in Monroe, NC.
- Primary shift: 1:00 PM – 10:00 PM.
- Training will be completed during day shift (8:00 AM – 5:00 PM, Monday–Friday) before release to later shift.
Compensation & Additional Info
- Estimated salary: $59,553 per year (estimated; provided by the source listing).
- This is a full-time position in a fast-paced, FDA-regulated pharmaceutical manufacturing environment.
- The role requires strict adherence to cGMP, GLP, and internal quality systems.
Reasonable Accommodations
Careertakes and our client are committed to providing reasonable accommodations to applicants and employees with disabilities in accordance with applicable law. If you need an accommodation in the application or hiring process, please indicate this through the appropriate channel when contacted.
Equal Opportunity & Hiring Transparency
Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.
If you have questions about how your data is used, please contact us directly.
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