Quality Assurance Specialist

hace 2 días


Añasco, Puerto Rico Labchems Corp. A tiempo completo

Job Overview

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At Labchems Corp., we are seeking a highly skilled Quality Assurance Specialist to support our facilities and construction projects. As a key member of the Core Team, you will participate in meetings and review/approve all documentation required for facility projects. Your primary responsibilities include developing technical documentation, such as Validation Protocols, Technical Investigation Reports, SOPs, Validation Plans, and Change Controls.

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Key Responsibilities:

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  • Support facilities and construction projects, focusing on quality system development and implementation to domestic and international standards.">
  • Develop and implement quality programs, including tracking, analyzing, reporting, and problem-solving.">
  • Plan, control, and assure product and process quality.">
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Requirements:

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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. Familiarity with HVAC, water filter systems, and cleanroom environments is also beneficial.

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Desirable Skills:

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  • Knowledge of reliability, maintainability, and risk management principles.">
  • Strong problem-solving and quality improvement techniques.">
  • Able to acquire and analyze data using standard quantitative methods.">
  • Familiarity with Lean and Six Sigma concepts and statistical techniques.">
  • Excellent interpersonal and project management skills.">
  • Technical writing skills.">


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