Sr Compliance Specialist, RD

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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.

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About Vision

Fueled by innovation at the intersection of biology and technology were 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 thats 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 patients lifetime.

Your unique talents will help patients on their journey to wellness. Learn more at 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 Bachelors 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 internal employees contact AskGS to be directed to your accommodation resource.

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