Quality Assurance Specialist for Pharmaceutical Manufacturing
1 week ago
You are invited to apply for a challenging role as a Quality Assurance Specialist at Yoh, working on-site with our pharmaceutical client in Noblesville, IN. This is a 6-month contract opportunity with a competitive salary.
Salary: $30-$40 per hour
About the Job
This position involves overseeing quality assurance processes for Validation, Engineering, and Maintenance at the site. You will be responsible for ensuring compliance with regulatory agencies, such as the FDA, and maintaining high-quality standards. Your strong technical and quality skills will enable you to succeed in this critical role. As a Senior Quality Assurance Engineer, you will report directly to the Senior Manager or Senior Director of Quality Assurance.
Your Key Responsibilities:
- Take a lead role in developing and maintaining facility quality systems and procedures.
- Review and approve Change Control/Process Management Documents involving product or process changes.
- Represent the company during on-site audits by regulatory agencies.
- Review and approve IOQs, requirement documents, SOPs, validation documents, and data integrity assessments.
- Analyze QA system data to ensure regulatory compliance, identify trends, and suggest areas for improvement.
- Conduct quality audits and develop corrective action recommendations.
- Develop procedures, statistical evaluations, and remediation of systems.
- Cultivate a safe and quality working environment through training and awareness.
- Maintain operational compliance with US and international regulatory agencies and guidelines.
Requirements:
- Bachelor of Science in Biology, Chemistry, Life Sciences, or a related field.
- Five or more years of relevant Quality or Validation experience in a finished pharmaceutical manufacturing environment.
- Experience supporting on-site inspections for regulatory agencies.
- Familiarity with applicable regulatory guidelines concerning test procedures, equipment, processes, and facility systems.
- Working knowledge of cGMP guidelines and their application in controlled aseptic environments.
- Ability to work collaboratively with other groups to resolve issues and close gaps.
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