Job Details

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 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