Senior Specialist, Quality Assurance Clinical Auditor

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.

We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Quality

Job Sub Function:
Quality & Compliance Audit

Job Category:
Professional

All Job Posting Locations:
Horsham, Pennsylvania, United States of America, Irvine, California, United States of America, La Jolla, California, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

We are searching for the best talent for Senior Specialist, Quality Assurance Clinical Auditor to join our Quality Organization located in Titusville, NJ; Raritan, NJ; Horsham, PA; Spring House, PA; Irvine, CA; or La Jolla, CA.

This is a hybrid position where the successful candidate will be expected to report to one of the listed sites 3x/week.

In R&D Quality, we continue to invest in our talent, diversity, and expertise, to make quality a business differentiator and competitive advantage - allowing our business partners to better deliver what really matters to customers and patients.

QA delivers innovative risk-based audit and quality control approaches that provide relevant insights to proactively secure compliance and drive sustainability and reliability across Johnson & Johnson Innovative Medicine.

Key responsibilities:

• Independently leads the planning, conduct and reporting of GCP QA routine audits and supports non-routine GCP audits including Clinical Investigator Site audits, Trial/Program audits, External Service Provider audits, Process/System audits, Local Operating Country audits, to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements.

Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope.

• Ensures the relevant standard procedures, audit tools, and audit plans are fully understood and applied in audit activities.

• Analyzes, interprets data and identifies patterns and trends in data sets.

• Ensures timely and appropriate review & delivery of CAPAs and actions arising from audits.

• Presents information logically a...