Johnson & Johnson Careers
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Sr. Product Release Specialist
Requisition ID: 3583180213
Johnson & Johnson Vision is currently recruiting for a Sr Product Release Specialist to be located in Jacksonville, FL.
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 serve an important role in the release of ACUVUE® Brand Contact Lenses for distribution. In this role you will:
- Reviews 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.
- Reviews 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.
- Leads the investigation and resolution process for nonconformance found during DHR review, with appropriate personnel and project leaders.
- Reviews and provides approval for all DHR documentation associated with New Product or Process Qualifications.
- Releases product from quarantine period in manufacturing to Distribution or R&D for Clinical Protocols.
- Coordinates with appropriate departments to prioritize work-in-progress.
- Files, and maintains long-term storage of manual records.
- Supports continuous quality improvement initiatives and participates on process excellence team as QA representative.
- Adheres to environmental policy and procedures and supports department environmental objectives.
- High School Degree or equivalent is required.
- 4+ years’ experience in a Quality Assurance/Regulatory Affairs environment (i.e. performing audits, reviewing large volumes of data in a short period, etc.) is preferred.
- Strong attention to detail and critical thinking skills required.
- Strong computer skills with the ability to learn new systems is required.
- Ability to work in a self-directed dynamic environment.
- Perform under pressure in a fast-paced environment.
- Knowledge of Quality System Regulations (GMPs) is required.
- Flexible work schedule to included overtime on short notice.
Johnson & Johnson Vision Care, Inc. (6094)