Sr Compliance Specialist, RD

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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:

R&D Operations

Job Sub Function:

Laboratory Operations

Job Category:

Professional

All Job Posting Locations:

Jacksonville, Florida, United States of America

Job Description:

About Vision

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for a Sr Compliance Specialist, R&D. This role is based on the campus in Jacksonville, FL.

Purpose: The Sr Compliance Specialist, R&D is primarily responsible for ensuring that the laboratories operate in compliance with FDA/GMP and ISO regulations. He/She facilitates the departmental non-conformance resolution process, performs internal assessments, analyzes quality/compliance trends and reports conclusions.

He/She applies trend results to prioritize the resolution of laboratory equipment, systems, and processes problems in order to prevent the occurrence of non-conformances. The Sr Specialist formulates departmental quality/compliance policies and procedures and conducts training on quality/compliance concepts and tools.

You will be responsible for:

• Ensure departmental compliance to FDA/GMP and ISO regulations, including the facilitation of the non-conformance resolution process and performing internal assessments.
• Track and trend quality/compliance performance and identifies key opportunities for improvement. Apply trend results to prioritize the resolution of laboratory equipment, systems, and processes problems in order to prevent recurrence of non-conformances.
• Formulate departmental quality/compliance policies and procedures and conduct training on quality/compliance concepts and tools.
• Provide leadership to facilitate problem solving in non-conformance and risk management.
• Serve as lead departmental representative on quality/compliance to R&D QA, Stability group, Compliance, external laboratories, IT.
• Lead projects for departmental quality/compliance improvement.
• Represents Analytical R&D as quality compliance SME for contract labs.
• Perform other related duties as assigned by management.

Qualifications:

Education:

• A minimum of a Bachelor’s degree is required, with a relevant technical field discipline (Analytical, Organic, Physical Chemistry) preferred

Skills & Experience:

• A minimum of 4 years’ experience in a regulated industry is required
• Medical device or pharmaceutical industry is preferred
• Thorough knowledge of FDA/GMP and ISO requirements in an R&D environment
• Thorough understanding of lab operations and analytical testing (chemical and physical) of raw materials, in-process samples and finished goods
• Ability to interpret regulations, corporate and company policies and then cascade into departmental quality/compliance procedures
• Excellent organizational, interpersonal, written, and oral communication skill
• Proven leadership, problem solving skills and project management experience
• Complete understanding and application of principles, concepts, and practices of Analytical Chemistry
• Certified Quality Auditor (CQA) certification preferred

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers internal employees contact AskGS to be directed to your accommodation resource.

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Required Skills:

Preferred Skills:

Analytical Reasoning, Business Behavior, Coaching, Communication, Data Management and Informatics, Data Savvy, Ethical and Participant Safety Considerations, Inventory Management, Laboratory Operations, Laboratory Safety, Mental Agility, Molecular Diagnostics, Preclinical Research, Problem Solving, Research and Development, Toxicology, Use of Laboratory Equipment