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LL02-061125 Laboratory Investigations Specialist
Validation & Engineering Group, IncManati, 091Hace 29 días
Descripción del trabajoBachelor'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. 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.
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 :
Responsibilities :
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Specialist • Manati, 091