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LL02-061125 Laboratory Investigations Specialist

LL02-061125 Laboratory Investigations Specialist

Validation & Engineering Group, IncManati, 091
Hace 29 días
Descripción del trabajo

Department : Field - LL Location : Manati, 091

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Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas : Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position :

  • Laboratory Investigations Specialist

Qualifications :

  • Bachelor's Degree in Science or Engineering.
  • Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.
  • Experience in Investigations within Laboratory Operations, QC Operations.
  • Must be fully bilingual (English / Spanish) with excellent oral skills.
  • Must be proficient using MS Windows and Microsoft Office applications.
  • Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
  • Strong knowledge (Laboratory for Pharmaceutical Site).
  • Excellent Technical Writing skills and investigations processes.
  • Available to work extended hours, possibility of weekends and holidays.
  • Responsibilities :

  • Investigate, draft, generate laboratory deviations or non-compliances.
  • Follow and implement investigations standard procedures.
  • Evaluate adequacy of quality assurance standards.
  • Review the implementation and efficiency of quality and inspection systems.
  • Plan, conduct and monitor testing and inspection of materials if needed for investigation process.
  • Investigate customer complaints and non-conformance issues.
  • Collect and compile statistical quality data.
  • Analyze data to identify areas for improvement in the quality system.
  • Develop, recommend and monitor corrective and preventive actions.
  • Prepare reports to communicate outcomes of quality activities.
  • Identify training needs and organize training interventions to meet quality standards.
  • Coordinate and support on-site audits conducted by external providers.
  • Evaluate audit findings and implement appropriate corrective actions.
  • Monitor risk management activities.
  • Responsible for document management systems.
  • Assure ongoing compliance with quality and industry regulatory requirements.
  • START YOUR APPLICATION

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    Specialist • Manati, 091