Environmental Monitoring Analyst

Stark Pharma Solutions Inc; Durham (NC); On-site; USD 70,000 - 100,000; Full time

Job summary

Stark Pharma Solutions Inc. in Durham, NC is seeking an Environmental Monitoring Analyst to own contamination control duties, dig into EM data, and strengthen GMP documentation for EU GMP Annex 1 readiness.

You will work with Quality, Microbiology, and Manufacturing, drive risk assessments, and shape how the site monitors contamination, reporting trends and CAPA opportunities.

Qualifications

• EU GMP Annex 1 knowledge required.
• Environmental monitoring and cleanroom experience.
• Documentation and data review skills.
• CAPA and risk assessment experience.
• Regulatory inspections exposure a plus.

Responsibilities

• Own EM data review and trending.
• Assess readiness for Annex 1 and drive remediation.
• Develop and maintain program documentation.
• Collaborate with Quality, Microbiology, and Manufacturing.
• Support CAPA and audit prep.

Skills

Data analysis

EM program experience

GMP documentation

Risk assessment

FMEA/HACCP

Technical writing

Education

Microbiology degree

Life sciences degree

Biotech/Engineering degree

Job description

Step Into a Role That Actually Matters

Contamination control isn't a back-office function , it's the line between a safe product and a recall.

We're looking for an Environmental Monitoring Analyst who wants real ownership of that line: someone ready to dig into EM data, sharpen GMP documentation, and help a pharmaceutical/medical device site get ahead of EU GMP Annex 1 requirements before they become a problem.

This isn't a role where you'll be buried in busywork.

You'll work directly with Quality, Microbiology, and Manufacturing teams, contribute to real risk assessments, and see your recommendations actually shape how the site monitors and controls contamination risk.

What You'll Own

• Dig into EU GMP Annex 1 readiness ; assess current EM practices, catch compliance gaps before auditors do, and drive remediation forward
• Own the data: track viable and non-viable monitoring results, sampling coverage, alert/action thresholds, and the trends that tell you something's shifting
• Bring structure to risk ; apply FMEA, HACCP, or risk ranking to real contamination scenarios and help shape how the site responds
• Build documentation that holds up ;EM program records, risk assessments, gap reports, CAPAs, SOPs, work instructions, and contamination control strategy (CCS) files
• Be the connective tissue across teams ; partner with Quality, Microbiology, and Manufacturing on Annex 1 readiness, excursion investigations, CAPA closure, and audit prep

What You Bring

• A degree in Microbiology, Life Sciences, Biotechnology, Pharmaceutical Sciences, Engineering, or a related technical field
• Real grounding in EU GMP Annex 1, environmental monitoring, contamination control, aseptic processing, and cleanroom discipline
• Hands-on exposure to EM programs ; sampling, alert/action levels, data review, trending
• A risk-based mindset ; comfort applying FMEA, HACCP, or risk ranking to real decisions
• Sharp technical writing ; you can turn complex GMP requirements into documentation people can actually use
• A bonus if you bring: ISO 14644 familiarity, CCS documentation experience, CAPA process knowledge, or exposure to regulatory inspections