QA Specialist III
Listed on 2026-07-01
-
Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, Regulatory Compliance Specialist, Quality Control - QC Analysts/Managers
QA Specialist III
Integrated 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 DescriptionLead/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
QualificationsIn 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
#J-18808-Ljbffr(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).