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Quality Associate II (Part-time)-Guaynabo
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Responsible for ensuring compliance of Sterility Assurance and Quality activities. Documents and Data Management: Audit and archive GMP documentation (SOPs/Forms), Revise local procedures, ensure all procedures are controlled and current versions are available to staff. Sterility Assurance: Request and perform Environmental daily Monitoring Testing, incubation and reading of samples, lead investigation records for Microbiological OOLs and particulate Matter OOLs. Quality System Measurement and Review: Quality Approve CPI records in CQI Workflow, Initiate Critical System Workorders, Service Complaint, CPIs, Micro-OOLs, Initiate/Own NCR and CAPA records and ensure investigations are completed. Support validation activities (process and equipment) Support audit process and perform inspections.

Requisitos:
 Requirements:
 Bachelor of Science Degree in Biology or Microbiology with a minimum of 1 year of experience in Quality processes and documentation systems. Experience in investigations (deviations, corrective and preventive actions). Strong computer skills (Microsoft Office and other). Strong understanding of GMP and aseptic process. Strong understanding of sterility assurance and environmental and microbiological control. Strong knowledge of Quality system management and implementation. Strong written and oral communication skills in Spanish and English. Excellent organization skills, ability to work with all levels of the organization and attention to detail. Thorough knowledge of applicable procedures, specifications, regulations and standards. Strong analytical and problem-solving skills and critical thinking abilities. Available Mon-Fri between 20-24 hours, temporary 4 months. 27692

Con Alguna Experiencia Requires Intermediate Experience

Beneficios:
Benefits Package:
 LabChemS Corp (LCC) is a leading company in consulting services, laboratories and support resources, primarily for the medical and pharmaceutical device industries in Puerto Rico and Costa Rica.
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Empleos en Puerto RicoJobs in Puerto Rico
LabChemS Corp.

Empleos en Puerto RicoJobs in Puerto Rico Profesionales
Guaynabo PR 00600 Guaynabo
# Clasificado 2222100 Classified # 2222100
LabChemS Corp.
DescripciónDescription Responsible for ensuring compliance of Sterility Assurance and Quality activities. Documents and Data Management: Audit and archive GMP documentation (SOPs/Forms), Revise local procedures, ensure all procedures are controlled and current versions are available to staff. Sterility Assurance: Request and perform Environmental daily Monitoring Testing, incubation and reading of samples, lead investigation records for Microbiological OOLs and particulate Matter OOLs. Quality System Measurement and Review: Quality Approve CPI records in CQI Workflow, Initiate Critical System Workorders, Service Complaint, CPIs, Micro-OOLs, Initiate/Own NCR and CAPA records and ensure investigations are completed. Support validation activities (process and equipment) Support audit process and perform inspections. Requisitos Requirements Bachelor of Science Degree in Biology or Microbiology with a minimum of 1 year of experience in Quality processes and documentation systems. Experience in investigations (deviations, corrective and preventive actions). Strong computer skills (Microsoft Office and other). Strong understanding of GMP and aseptic process. Strong understanding of sterility assurance and environmental and microbiological control. Strong knowledge of Quality system management and implementation. Strong written and oral communication skills in Spanish and English. Excellent organization skills, ability to work with all levels of the organization and attention to detail. Thorough knowledge of applicable procedures, specifications, regulations and standards. Strong analytical and problem-solving skills and critical thinking abilities. Available Mon-Fri between 20-24 hours, temporary 4 months. 27692
Con Alguna Experiencia Requires Intermediate Experience BeneficiosBenefits Package LabChemS Corp (LCC) is a leading company in consulting services, laboratories and support resources, primarily for the medical and pharmaceutical device industries in Puerto Rico and Costa Rica.
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LabChemS Corp.

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