Johnson & Johnson Vision, a member of Johnson & Johnson's Family of Companies, is recruiting for a Sr. Product Release Specialist located in Jacksonville, Florida.
Johnson & Johnson Vision is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, it has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses. In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
As the Sr. Product Release Specialist, you will:
- Review electronic and manual records pertinent to device history and sterilization ensuring all records are in compliance with company and government regulations prior to release of product.
- Review DHR for clinical protocols for products used in clinical applications and ensures device history records are completed and released in accordance with company and government regulations.
- Lead the investigation and resolution process for nonconformance found during DHR review, with appropriate personnel and project leaders.
- Review and provides approval for all DHR documentation associated with New Product or Process Qualifications.
- Release product from quarantine period in manufacturing to Distribution or R&D for Clinical Protocols.
- Coordinate with appropriate departments to prioritize work-in-progress.
- File, and maintain long-term storage of manual records.
- Support continuous quality improvement initiatives and participates on process excellence team as QA representative.
- Adhere to environmental policy and procedures and supports department environmental objectives.
- A High School Diploma is required.
- At least four (4) years of experience in a regulated industry is required.
- Experience in a Quality Assurance/Regulatory Affairs environment (i.e. performing audits, reviewing large volumes of data in a short period, etc.) is preferred.
- Knowledge of Quality System Regulations (GMPs) is required.
- Strong computer skills, including Windows Operating Systems and applications or equivalent required.
- Must be available for flexible work schedule to included overtime on short notice.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Johnson & Johnson Vision Care, Inc. (6094)