Our client, a global pharmaceutical company is looking to add a Senior Quality Assurance Associate to their team in Ohio. This is a permanent, full-time role. Responsibilities include performing commercial Supplier Quality Management activities. This includes execution of vendor audits, quality agreements, lifecycle management, and changes and complaints to external vendors. The candidate will also perform general QA work, using their ability as a skilled contributor in completing tasks where judgment is required in resolving problems and making recommendations.

Responsibilities:

• Supplier Quality Management of commercial materials and service providers
• Lead external audits, write associated audit reports, and follow-up on actions related to audits observations
• Evaluate change control records and manage supplier change notifications
• Coordinate Quality Agreements both new and periodic reviews
• Perform risk assessments and associated risk mitigation plans
• Coordinate supplier nonconformance investigations with vendors
• Notifies management of any atypical trend observed in the quality systems
• Substitutes or represents the QA Manager in meetings and/or projects as needed
• Supports the QA Manager in the coordination of key responsibilities in the area of responsibility
• Develop Standard Operating Procedures and other quality related documents
• Review and approve written procedures and other documents
• Interact with vendors and plant personnel to insure CGMP compliance
• Provide support to projects, metrics and other quality systems, when needed

Requirements:

• BS in scientific discipline or equivalent
• 8-10 years’ experience in a Quality Assurance role in the pharmaceutical industry; preferably with parenteral and oral dosage forms.
• Broad experience performing supplier audits
• Auditor certification preferred
• Working knowledge of US and European Drug Product GMP requirements and associated guidelines, including ISO 9001, ISO13485, and data integrity with ability to increase others knowledge
• Willing to travel up to 30%