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Company Overview
QUALITY CONSULTING GROUP is a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry. Our mission is to provide expert consulting services to ensure compliance with federal regulations.
Job Description
We are seeking a highly motivated Quality Assurance Specialist to join our team. In this role, you will be responsible for conducting compliant validation processes for quality information technology systems. You will work closely with clients, programmers/developers, and operating personnel to ensure that all activities meet regulatory requirements.
Key Responsibilities:
- Conducts compliant validation process for quality information technology systems.
- Cordinates activities with clients, programmers/developers, and operating personnel.
- Identifies current and anticipated requirements for compliant computerized operations.
- Suggests methods for the identification, implementation, and maintenance of procedures, actions, and documentation necessary to assure compliance.
Qualifications:
- Bachelor degree in Engineering or Science.
- 7 years of relevant experience.
- Experience in Process Validation and Computer System Validation.
- Medical Devices regulatory experience.
- Problem solving method.
- Risk assessment.
- Ability to use statistical techniques to analyze data.
- Capable of developing/reviewing/approving test plans and reports.
- Experience in medical devices manufacturing.
- Interpersonal Skills.
- Investigate and collaborate in the investigation of atypical events to support product disposition.
- PFMEA.
- Applied statistical analysis.
- Investigation and root cause analysis skills.
- Technical writing knowledge.