QA Specialist III

• 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

• 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

Feel free to forward my email to your friends/colleagues who might be available. We do offer referral Bonus.

Thank you.

Kind Regards,

Harris Kaushik

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

DIRECT # - (732)-844-8715

Gold Seal JCAHO Certified ™ for Health Care Staffing

“INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)