EM Analyst

Are you a budding professional with a passion for Environmental Monitoring and GMP compliance? This role as an EM Analyst in Durham, NC, offers a unique chance to develop your career within a dynamic and supportive environment.

About the role

This is a 6-month contract position with a competitive rate of up to $40/hr for the right candidate, providing hands-on experience and growth opportunities in the industry.

Responsibilities

• Support EU GMP Annex 1 gap assessments by reviewing Environmental Monitoring practices, identifying compliance gaps, and assisting with remediation activities.
• Assist with Environmental Monitoring program activities, including review of viable and non-viable monitoring data, sampling locations, frequencies, alert/action levels, and EM trends.
• Support risk assessments using established methodologies such as FMEA, risk ranking, or HACCP to evaluate contamination risks and provide input into monitoring strategies and mitigation activities.
• Prepare and update GMP documentation, including EM program documents, risk assessments, gap assessment reports, CAPAs, SOPs, work instructions, CCS documentation, and trend reports under appropriate guidance and review.

Requirements

• Bachelor's degree in Microbiology, Life Sciences, Biotechnology, Pharmaceutical Sciences, Engineering, or a related scientific/technical discipline.
• Foundational understanding of EU GMP Annex 1, Environmental Monitoring, contamination control, aseptic processing, cleanroom practices, and GMP requirements.
• Exposure to Environmental Monitoring programs, including viable/non-viable monitoring, sampling strategies, alert/action levels, data review, and trending.
• Familiarity with risk assessment methodologies such as FMEA, HACCP, or risk ranking, with the ability to apply risk-based thinking to GMP and contamination control activities.

Pay

Up to $40/hr.

Schedule

6-month contract position.