Product Release Specialist II

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:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Business Enablement/Support

All Job Posting Locations:

Jacksonville, Florida, United States of America

Job Description:

About MedTech

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

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 Product Release Specialist II.

Purpose: Responsible for release of batch records from Quality Operations through review of electronic and/or manual device history to ensure quality standards are met. The product release specialist will follow prescribed steps to document issues and follow-up on corrective actions, as needed. Documents batch release process and mentors less experienced staff on implementation. Reviews batch files to ensure storage and maintenance is in accordance with business policies. Makes recommendations and provides support to corrective actions. Administers requests for rework and destruction of materials. Adheres to environmental policy and procedures and supports department environmental objectives.

You will be responsible for:

1. Reviews electronic and manual records pertinent to device history and sterilization. Investigates and resolves discrepancies.

2. Participates in training and development of Product Release staff.

3. Responsible for manual DHR documents to be filed for storage per procedure.

4. Participates in the development and implementation of new systems directly and indirectly impacting Product Release.

Qualifications/Requirements:

Experience and Education

High School Degree or equivalent.

1-3+ years experience in a Quality Assurance/Regulatory Affairs environment (e.g. performing audits, reviewing large volumes of data in a short period of time, etc)

Knowledge of Quality System Regulations (GMPs), preferred

Knowledge of validated JJV systems (eDHR, MES, VIBES), preferred

Required Knowledge, Skills, Abilities, Certifications/Licenses and Affiliations

Strong attention to detail and critical thinking skills

Ability to work in a self-directed dynamic environment.

Perform under pressure in a fast paced environment.

Flexible work schedule to included overtime on short notice.

Location and Travel Requirements

Location:

• Jacksonville, FL

Travel:

• <5%

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:

Accountability, Administrative Support, Communication, Compliance Management, Document Management, Execution Focus, Goal Attainment, Process Oriented, Product Knowledge, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Report Writing, Statistical Process Control (SPC)