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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. With a competitive rate of up to $40/hr for the right fit and a 6-month duration, this position provides a platform for growth and hands-on experience in the industry.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the EM Analyst will be varied however the key duties and responsibilities are as follows:
1. Support EU GMP Annex 1 gap assessments by reviewing Environmental Monitoring practices, identifying compliance gaps, and assisting with remediation activities.
2. Assist with Environmental Monitoring program activities, including review of viable and non-viable monitoring data, sampling locations, frequencies, alert/action levels, and EM trends.
3. 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.
4. 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.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the EM Analyst we are looking to identify the following on your profile and past history:
1. Bachelor's degree in Microbiology, Life Sciences, Biotechnology, Pharmaceutical Sciences, Engineering, or a related scientific/technical discipline.
2. Foundational understanding of EU GMP Annex 1, Environmental Monitoring, contamination control, aseptic processing, cleanroom practices, and GMP requirements.
3. Exposure to Environmental Monitoring programs, including viable/non-viable monitoring, sampling strategies, alert/action levels, data review, and trending.
4. 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.
If you are ready to take the next step in your career and contribute to a leading organisation in the industry, apply now to become an integral part of a team dedicated to excellence in Environmental Monitoring and GMP compliance.
Key Words: Environmental Monitoring / GMP compliance / EU GMP Annex 1 / contamination control / aseptic processing / cleanroom practices / risk assessment / FMEA / HACCP / CAPA
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
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. With a competitive rate of up to $40/hr for the right fit and a 6-month duration, this position provides a platform for growth and hands-on experience in the industry.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the EM Analyst will be varied however the key duties and responsibilities are as follows:
1. Support EU GMP Annex 1 gap assessments by reviewing Environmental Monitoring practices, identifying compliance gaps, and assisting with remediation activities.
2. Assist with Environmental Monitoring program activities, including review of viable and non-viable monitoring data, sampling locations, frequencies, alert/action levels, and EM trends.
3. 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.
4. 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.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the EM Analyst we are looking to identify the following on your profile and past history:
1. Bachelor's degree in Microbiology, Life Sciences, Biotechnology, Pharmaceutical Sciences, Engineering, or a related scientific/technical discipline.
2. Foundational understanding of EU GMP Annex 1, Environmental Monitoring, contamination control, aseptic processing, cleanroom practices, and GMP requirements.
3. Exposure to Environmental Monitoring programs, including viable/non-viable monitoring, sampling strategies, alert/action levels, data review, and trending.
4. 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.
If you are ready to take the next step in your career and contribute to a leading organisation in the industry, apply now to become an integral part of a team dedicated to excellence in Environmental Monitoring and GMP compliance.
Key Words: Environmental Monitoring / GMP compliance / EU GMP Annex 1 / contamination control / aseptic processing / cleanroom practices / risk assessment / FMEA / HACCP / CAPA
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
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