Kelly Science, Engineering, Technology & Telecom · 1 day ago
Senior Quality Assurance Specialist
Rochester, New York Metropolitan Area
Contract
Onsite
Senior Level
$45/hr - $60/hr
5+ years expKelly Science is seeking a Senior Quality Assurance Specialist for a short term contract with a growing company located in Rochester, NY. The role involves managing deviations, CAPAs, and change controls, as well as collaborating across disciplines to implement quality improvements.
Staffing & Recruiting
Hiring Manager
Paula Picard
Responsibilities
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
Qualification
Required
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
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Linda Stuit
Senior Vice President, Engineering Specialty
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