Validation Support Specialist

Company Description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

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Job Description

Validation Support is responsible for providing support to the manufacturing areas related to process and product activities, giving assistance on new product introduction, product and process changes, maintenance of validation program, investigations and promoting continuous improvement of medical devices manufacturing. 

Duties:

• Provide technical support to manufacturing engineering and quality areas.
• Participate on the evaluation of customer complaints, NCR Investigations, to provide technical support for process/product analysis for corrective and/or preventive actions during non-conformance investigations. 
• Support and maintain process or product validations and re-validation programs (IQ/OQ/PQ) using local or divisional engineering resources.
• Generate validation protocols and reports for the qualification of process equipment or process changes.
• Assist in the preparation and review of validation documentation, including test scripts, reports, and traceability matrices
• Develop and update standard operating procedures for new and/or existing processes and equipment. 
• Participate in risk assessments and change control processes related to validation scope. 
• Promote a zero-harm workplace and assure that required EHS resources are available and that all applicable EHS practices and rules are being followed by supervised employees.
• Observe confidentiality and data privacy rules at all times. 

Qualifications

• Bachelor Degree in Science or Engineering. 
• 1-2 years of experience in regulated industry.  
• Ability to work as a collaborative team member.
• Computer Applications to do process analysis. 
• Knowledge or problem solving and statistical techniques. 
• Bilingual (English & Spanish)  

Additional Information

All your information will be kept confidential according to EEO guidelines.