Johnson & Johnson companies are equal opportunity employers.
Staff Change Control Specialist-8990140418
Description
Vistakon, a Johnson & Johnson Company, is currently recruiting for a Staff Change Control Specialist located in Jacksonville, FL.
Johnson & Johnson Vision Care, Inc., Vistakon® Division of Johnson & Johnson Vision Care, Inc., specializes in disposable contact lenses, which it markets under ACUVUE® Brand contact lenses. Ever since ACUVUE® transformed vision correction in 1988 with the world's first soft disposable contact lenses, we've passionately pursued new technologies and the highest quality standards. We're proud that ACUVUE® lenses are worn by more people than any other brand.
The Staff Change Control Specialist is responsible for the Franchise administration of quality systems such as Global Change Control (GCC) and Global Application Change Control including ensuring the change request program is well-defined, executable, meeting customer and business needs, and in compliance with regulatory, sector, and franchise requirements. The individual is responsible for analyzing and monitoring efficiency and effectiveness of metrics associated with Change Control. He/she proactively examines change control systems, processes and standards to identify areas for review, change or eliminate. The Staff Change Control Specialist establishes linkages to other key quality systems/programs such as Design Controls and Risk Management. The individual supports process owners in completing change requests and provides leadership in related technical reviews of change requests providing guidance in the area of compliance to current regulations and standards governing change control.
The Staff Change Control Specialist will franchise administration of Global Change Control (GCC) and Global Application Change Control programs. The individual will ensure linkages to Nonconformances (NC), Root Cause Investigations (RCI), Corrective Actions/Preventive Actions (CAPA), business unit and site management reviews, Validation, and Risk Management. He/she will support Technical Review Board discussions and follows up on action items from these discussions, as well as train business partners on GCC and GACC platforms. This position adheres to environmental policy, procedures, and supports department environmental objectives.
Qualifications
A minimum of a Bachelors Degree or a minimum of eight (8) years of relevant professional business experience is required. A minimum of six (6) years of professional experience working in the Quality Assurance, Compliance or Regulatory Affairs industries is required. An in-depth knowledge of FDA / ISO requirements, with specific focus on change control, quality, operations systems and processes is required. Proficiency with Microsoft Excel is required.
This position is located in Jacksonville, FL and may require up to 10% travel.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-Florida-Jacksonville
Organization: Johnson & Johnson Vision Care, Inc. (6094)
Job Function: Quality (Generalist)
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
Staff Change Control Specialist-8990140418
Description
Vistakon, a Johnson & Johnson Company, is currently recruiting for a Staff Change Control Specialist located in Jacksonville, FL.
Johnson & Johnson Vision Care, Inc., Vistakon® Division of Johnson & Johnson Vision Care, Inc., specializes in disposable contact lenses, which it markets under ACUVUE® Brand contact lenses. Ever since ACUVUE® transformed vision correction in 1988 with the world's first soft disposable contact lenses, we've passionately pursued new technologies and the highest quality standards. We're proud that ACUVUE® lenses are worn by more people than any other brand.
The Staff Change Control Specialist is responsible for the Franchise administration of quality systems such as Global Change Control (GCC) and Global Application Change Control including ensuring the change request program is well-defined, executable, meeting customer and business needs, and in compliance with regulatory, sector, and franchise requirements. The individual is responsible for analyzing and monitoring efficiency and effectiveness of metrics associated with Change Control. He/she proactively examines change control systems, processes and standards to identify areas for review, change or eliminate. The Staff Change Control Specialist establishes linkages to other key quality systems/programs such as Design Controls and Risk Management. The individual supports process owners in completing change requests and provides leadership in related technical reviews of change requests providing guidance in the area of compliance to current regulations and standards governing change control.
The Staff Change Control Specialist will franchise administration of Global Change Control (GCC) and Global Application Change Control programs. The individual will ensure linkages to Nonconformances (NC), Root Cause Investigations (RCI), Corrective Actions/Preventive Actions (CAPA), business unit and site management reviews, Validation, and Risk Management. He/she will support Technical Review Board discussions and follows up on action items from these discussions, as well as train business partners on GCC and GACC platforms. This position adheres to environmental policy, procedures, and supports department environmental objectives.
Qualifications
A minimum of a Bachelors Degree or a minimum of eight (8) years of relevant professional business experience is required. A minimum of six (6) years of professional experience working in the Quality Assurance, Compliance or Regulatory Affairs industries is required. An in-depth knowledge of FDA / ISO requirements, with specific focus on change control, quality, operations systems and processes is required. Proficiency with Microsoft Excel is required.
This position is located in Jacksonville, FL and may require up to 10% travel.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:North America-United States-Florida-Jacksonville
Organization: Johnson & Johnson Vision Care, Inc. (6094)
Job Function: Quality (Generalist)
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement