Regulatory Compliance Officer

hace 3 días


Añasco, Puerto Rico Labchems Corp. A tiempo completo

About the Role

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Labchems Corp. is looking for a Regulatory Compliance Officer to join our team. In this role, you will be responsible for ensuring compliance with quality standards and regulations in our facilities and construction projects. You will develop and implement quality programs, track and analyze data, and report findings to ensure product and process quality.

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Main Responsibilities:

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  • Support facilities and construction projects by reviewing and approving documentation related to quality systems.">
  • Develop and implement quality programs to meet domestic and international standards.">
  • Analyze data to identify areas for improvement and implement corrective actions.">
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Qualifications:

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We require a Bachelor's degree in Chemical, Biomedical, Mechanical, or Industrial Engineering, with 5-7 years' experience in a FDA-regulated environment. ASQ Certified Quality Engineer and/or Quality Auditor certification is preferred, along with experience in biomaterials or Lyophilization. Strong knowledge of Quality System Regulation, ISO, Design Control, and Process Validation is essential.

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Additional Requirements:

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  • Experience with cleanroom environments and HVAC systems.">
  • Knowledge of reliability, maintainability, and risk management principles.">
  • Strong analytical and problem-solving skills.">
  • Excellent communication and interpersonal skills.">


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