LL02-061125 Laboratory Investigations Specialist

Job Description

Job Description

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.