Quality Assurance Specialist – Utilities & Environmental Monitoring

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    "url": "https://mentortechnicalgroup.applytojob.com/apply/jobs/details/Vs4rX3c12F?&",
    "heading": "Quality Assurance Specialist – Utilities & Environmental Monitoring",
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    "description_html": "<p><em>Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.</em></p><p><strong>Responsibilities:</strong></p><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><b><span style=\"color:#2b2b2b;\">Sampling Collection & Environmental Monitoring</span></b></span></span><ul style=\"margin-top:3px;margin-bottom:3px;\"><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Perform sample collection and quality monitoring oversight of PR05 Utilities Systems (e.g., water systems, steam, compressed gases) and the Environmental Monitoring Program (e.g., room air – viable and non-viable, contact plates).</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Ensure timely sample collections in accordance with the applicable sampling plan or protocol and in compliance with procedural requirements.</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Support QA oversight of Site Utilities Systems and Environmental Monitoring results.</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Coordinate with impacted areas including the laboratory, utilities, and manufacturing operations.</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Ensure appropriate and correct use of applicable equipment for sample collection and delivery.</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Apply and assure appropriate aseptic techniques during all sampling activities.</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Ensure timely approval and reporting of applicable sampling results.</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Maintain appropriate documentation in compliance with Good Documentation Practices (GDP) and data integrity requirements.</span></span></span></li></ul><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><b><span style=\"color:#2b2b2b;\">Quality Oversight & Compliance</span></b></span></span><ul style=\"margin-top:3px;margin-bottom:3px;\"><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Provide Quality Assurance oversight to GMP manufacturing operations.</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Adhere to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP).</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Serve as a reviewer of GMP and quality-related SOPs, as applicable.</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Provide QA assistance and feedback to utilities and operational staff.</span></span></span></li></ul><div style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><b><span style=\"color:#2b2b2b;\">Inspection Readiness & Continuous Improvement</span></b></span></span></div><ul style=\"margin-top:3px;margin-bottom:3px;\"><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Support the execution of inspection readiness activities, including participation in self-inspection activities when required.</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Maintain quality systems and proactively suggest process improvements.</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Escalate quality issues to the site-based process team in a timely manner.</span></span></span></li></ul><br><strong>Qualifications Requirements/Knowledge/Education/Skills:</strong><ul style=\"margin-top:3px;margin-bottom:3px;\"><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:10pt;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Bachelor’s Degree (minimum) in a science, engineering, or pharmaceutical-related field.</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:10pt;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">One (1) to three (3) years of experience in a GMP- and FDA-regulated environment in roles such as Quality Assurance, Quality Control Laboratory, Manufacturing, or Technical Services.</span></span></span></li></ul><p><br />\n<strong>Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.</strong></p>\n\n<p><em><strong>Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.</strong></em></p>",
    "description_text": "Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.\n Responsibilities:\n Sampling Collection & Environmental Monitoring Perform sample collection and quality monitoring oversight of PR05 Utilities Systems (e.g., water systems, steam, compressed gases) and the Environmental Monitoring Program (e.g., room air – viable and non-viable, contact plates).\n Ensure timely sample collections in accordance with the applicable sampling plan or protocol and in compliance with procedural requirements.\n Support QA oversight of Site Utilities Systems and Environmental Monitoring results.\n Coordinate with impacted areas including the laboratory, utilities, and manufacturing operations.\n Ensure appropriate and correct use of applicable equipment for sample collection and delivery.\n Apply and assure appropriate aseptic techniques during all sampling activities.\n Ensure timely approval and reporting of applicable sampling results.\n Maintain appropriate documentation in compliance with Good Documentation Practices (GDP) and data integrity requirements.\n Quality Oversight & Compliance Provide Quality Assurance oversight to GMP manufacturing operations.\n Adhere to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP).\n Serve as a reviewer of GMP and quality-related SOPs, as applicable.\n Provide QA assistance and feedback to utilities and operational staff.\n Inspection Readiness & Continuous Improvement\n Support the execution of inspection readiness activities, including participation in self-inspection activities when required.\n Maintain quality systems and proactively suggest process improvements.\n Escalate quality issues to the site-based process team in a timely manner.\n Qualifications Requirements/Knowledge/Education/Skills: Bachelor’s Degree (minimum) in a science, engineering, or pharmaceutical-related field.\n One (1) to three (3) years of experience in a GMP- and FDA-regulated environment in roles such as Quality Assurance, Quality Control Laboratory, Manufacturing, or Technical Services.\n Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.\n Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.",
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      "datePosted": "2026-05-26",
      "description": "<p><em>Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.</em></p><p><strong>Responsibilities:</strong></p><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><b><span style=\"color:#2b2b2b;\">Sampling Collection & Environmental Monitoring</span></b></span></span><ul style=\"margin-top:3px;margin-bottom:3px;\"><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Perform sample collection and quality monitoring oversight of PR05 Utilities Systems (e.g., water systems, steam, compressed gases) and the Environmental Monitoring Program (e.g., room air – viable and non-viable, contact plates).</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Ensure timely sample collections in accordance with the applicable sampling plan or protocol and in compliance with procedural requirements.</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Support QA oversight of Site Utilities Systems and Environmental Monitoring results.</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Coordinate with impacted areas including the laboratory, utilities, and manufacturing operations.</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Ensure appropriate and correct use of applicable equipment for sample collection and delivery.</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Apply and assure appropriate aseptic techniques during all sampling activities.</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Ensure timely approval and reporting of applicable sampling results.</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Maintain appropriate documentation in compliance with Good Documentation Practices (GDP) and data integrity requirements.</span></span></span></li></ul><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><b><span style=\"color:#2b2b2b;\">Quality Oversight & Compliance</span></b></span></span><ul style=\"margin-top:3px;margin-bottom:3px;\"><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Provide Quality Assurance oversight to GMP manufacturing operations.</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Adhere to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP).</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Serve as a reviewer of GMP and quality-related SOPs, as applicable.</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Provide QA assistance and feedback to utilities and operational staff.</span></span></span></li></ul><div style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><b><span style=\"color:#2b2b2b;\">Inspection Readiness & Continuous Improvement</span></b></span></span></div><ul style=\"margin-top:3px;margin-bottom:3px;\"><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Support the execution of inspection readiness activities, including participation in self-inspection activities when required.</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Maintain quality systems and proactively suggest process improvements.</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:12px;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Escalate quality issues to the site-based process team in a timely manner.</span></span></span></li></ul><br><strong>Qualifications Requirements/Knowledge/Education/Skills:</strong><ul style=\"margin-top:3px;margin-bottom:3px;\"><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:10pt;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">Bachelor’s Degree (minimum) in a science, engineering, or pharmaceutical-related field.</span></span></span></li><li style=\"margin-top:3px;margin-bottom:3px;margin-left:8px;\"><span style=\"font-size:10pt;\"><span style=\"font-family:Arial, sans-serif;\"><span style=\"color:#555555;\">One (1) to three (3) years of experience in a GMP- and FDA-regulated environment in roles such as Quality Assurance, Quality Control Laboratory, Manufacturing, or Technical Services.</span></span></span></li></ul><p><br />\n<strong>Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.</strong></p>\n\n<p><em><strong>Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.</strong></em></p>",
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