An Environmental Planner or Scientist uses training and background in natural sciences to study the environment and threats to the environment. Investigates environmental problems and advises on solutions. May focus on potential environmental health risks to people, such as unsafe drinking water, or on protecting the environment and ecosystems from human activity such as development and industrial pollution.
EM Analyst#26-08259
$39.29 per hour
Durham, NC
Onsite Job Description
At-a-Glance:
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring an EM Analyst.
Position Type:
Contract
On-Site Required:
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.
Strong written and verbal communication skills with the ability to prepare clear GMP documentation, technical reports, and supporting assessments while collaborating effectively with cross-functional teams; familiarity with ISO 14644, CCS, CAPA, or regulatory inspection activities is preferred.
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.
Collaborate with Quality, Microbiology, Manufacturing, and other site teams to support Annex 1 readiness, EM excursion investigations, CAPA activities, audit preparation, and continuous improvement initiatives.
Get in
Touch:
We want to hear from you! If you think you'd be a good match, submit your resume and reach out to Vaibhav at 551-227-9117 to learn more. #LI-VK1
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