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 VisionFueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
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Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
We are searching for the best talent for a Sr. Compliance Specialist, R&D. Job Position Summary 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.
Duties & Responsibilities 1. Ensure departmental compliance to FDA/GMP and ISO regulations, including the facilitation of the non-conformance resolution process and performing internal assessments.
2. 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.
3. Formulate departmental quality/compliance policies and procedures and conduct training on quality/compliance concepts and tools.
4. Provide leadership to facilitate problem solving in non-conformance and risk management.
5. Serve as lead departmental representative on quality/compliance to R&D QA, Stability group, Compliance, external laboratories, IT.
6. Lead projects for departmental quality/compliance improvement.
7. Represents Analytical R&D as quality compliance SME for contract labs.
8. Perform other related duties as assigned by management.
Experience & Education - (5)+ years experience in a regulated industry. Medical device or pharmaceutical industry is preferred
- Bachelor's degree in a relevant technical field preferred (Analytical, Organic, Physical Chemistry)
Required Knowledge, Skills, Abilities, Certifications/Licenses and Affiliations - 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 but not required
#LI-Onsite 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
