Senior Quality Assurance Specialist

Kelly Science is seeking a Senior Quality Assurance Specialist for a short term contract with a growing company located in Rochester, NY.

Pay: $45-60/hour

Shift: Monday-3:30pm (flexible)

Work Model: 100% on-site

Employment Type: 3-5 month contract

• Manage and handle deviations, CAPAs, and change controls across the workflow.
• Review and approve deviations and change controls, ensuring appropriate detail in all documentation.
• Investigate product complaints, analyze batch records and associated data, and identify resources needed for thorough investigations.
• Collaborate across disciplines to determine and implement corrective and preventive measures for quality improvement.
• Coordinate and summarize investigation documentation, including submitting complaints for final QA approval and assisting with CAPA preparation.
• Analyze complaints to identify trends and provide reviews for annual product evaluations.
• Develop, document, and implement standardized business processes; utilize quantitative techniques to monitor performance.
• Evaluate and enhance SOPs, implement change control documentation, and drive efficiency improvements while maintaining effectiveness.
• Apply knowledge of regulatory requirements and industry trends to advance process quality and compliance.

• Bachelor's degree in a scientific related field
• 5+ years of quality assurance experience within a FDA regulated, fast paced environment; preferably pharmaceuticals.
• Experience in managing quality investigations including CAPAs, change controls and deviations. Experience in laboratory deviations is highly desirable.
• Must be able to pivot when priorities change, collaborate with others and work well in fast paced environments.

Interested? Please apply today for immediate consideration!