QA Specialist III
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Overview
Job Description
QA Specialist IIIIntegrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.Job Description• Lead/participate in project team to streamline Clinical QA processes and SOPs by reviewing existing workflows and identifying areas for improvement.• Perform SOPs periodic review, write/revise SOPs and design process flowcharts• Responsible for ensuring CAPA/ audit observations responses are appropriately implemented and closed in a timely manner• Coordinate inspection and audit support for Clinical QA during internal / regulatory inspections and audits• Manage Clinical QA training requirements and curricula, OJT qualification programs, and New Employee Onboarding programs to drive improved employee qualification and training compliance• Maintain systems for organizing, tracking, trending and reporting Deviation, CAPA, batch disposition and review metrics• Review existing quality workflows and assist in identifying areas for improvement. Write, revise and may review standard operating procedures.• Other responsibilities as assigned
Qualifications• In depth knowledge of Quality Systems and international cGMP standards• In depth knowledge and experience with Operational Excellence Principles• An accountable team player who is detail and quality oriented with an in-depth understanding of quality assurance principles, systems and procedures• Excellent attitude with good verbal and interpersonal communication skills, excellent judgment, and multitasking skills who can work well in a dynamic environment• Strong leadership and negotiation skills• An accountable leader who is detail and quality oriented with a solid understanding of quality principles, methods, and procedures• Critical and strategic thinking skills• Working knowledge of GMPs and regulatory requirements (US, Canada, and EU)• Experience generating key metrics• Technical writing skills
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