Job Description
Duration: 6+ Months
Location: Durham, NC 27712
About the Role
We are seeking an Environmental Monitoring Analyst to support quality operations within a regulated pharmaceutical manufacturing environment. This role is critical in maintaining environmental and utility monitoring programs to ensure compliance with GMP and regulatory standards.
The ideal candidate will have hands-on experience in microbiological laboratory operations, aseptic manufacturing, or environmental monitoring, along with a strong attention to detail and commitment to quality and safety.
Responsibilities
- Collect and test qualified utility systems, including Clean Steam, WFI, and compressed gases.
- Perform environmental sampling of classified areas (active air, surface, and non-viable air sampling).
- Conduct personnel monitoring and routine sampling activities.
- Read EM plates and perform analyses such as TOC, conductivity, and gas testing.
- Enter, review, and approve data in LIMS and related systems.
- Compile and evaluate environmental data, identify adverse trends, and provide summaries to stakeholders.
- Support performance qualification and re-qualification activities.
- Manage equipment calibration, logbook control, and documentation filing.
- Author and review reports, protocols, and annual product reviews.
- Perform additional GMP-related duties as assigned by management.
Qualifications
- Required Education: Associate’s degree in a science-related field.
- Preferred Education: Bachelor’s degree in Biological Sciences.
Required Experience and Skills:
- Minimum 1 year of relevant post-degree experience in environmental monitoring, aseptic manufacturing, or microbiological laboratory operations.
- Strong oral and written communication skills.
- Ability to work independently while maintaining attention to detail and following GMP requirements.
- Knowledge of regulatory and quality standards in pharmaceutical or vaccine manufacturing.
- Physical ability to sit, stand, perform repetitive tasks, and lift up to 50 lbs.
Preferred Experience and Skills:
- GMP-based EM sampling experience in a pharmaceutical environment.
- Familiarity with Quality Control, Quality Assurance, cGMP practices, and GLIMS.
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