Quality Systems Specialist, Change Control

Job description

Ethicon, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Quality Systems Specialist- Change Control , located in Somerville, New Jersey.

The Ethicon business offers a broad range of products, platforms and technologies-including sutures, hemostasis products, surgical staplers, trocars and synthetic mesh devices-that are used in a wide variety of open and minimally invasive surgical procedures, and energy based surgical devices. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of surgery. Ethicon Endo-Surgery, Inc. was started within Ethicon, and was separated and moved to Cincinnati, Ohio over 20 years ago, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today along with innovative energy devices for surgery.

The Quality Systems Specialist is to serve as a local Product Lifecycle Management (PLM) change specialist for enforcing the change management process for controlled documents within the PLM system.

· This includes the creation of a new document, revisions to existing documents and verifying that all existing procedures affected by the change have been followed per governing change control procedures;
· Serve as franchise Learning Management System (LMS) administrator for enforcing training assignment related to controlled document deployment and other training initiatives, as needed;
· Independently evaluating business relative to GMP (Good Manufacturing Practices), QSR (Quality System Regulation), GLP (Good Laboratory Practices), GCP (Good Clinical Practices), ISO (International Organization for Standardization), MDD (Medical Devices Directive) and corporate business requirements (depending on areas of assigned focus); Supporting development and implementation of quality systems designed to ensure continuous production of product consistent with established standards and customer expectations; Leading development and implementation of global ISO based regulatory systems that ensure compliance with ISO, MDD, GMP, QSR regulations and international standards (as applicable), as well as internal JNJ standards;
· Provide administrative support of multiple QA PLM applications and associated processes; primarily the training learning management system (LMS) and Change Control Systems (Adaptiv/EPI); Support system upgrades. Maintain user databases, access, and profiles;
· Review Change Orders for compliance, quality, integrity, clerical correctness and procedure conformance. Ensure that associated training is accurately set up and executed through the Adaptiv / LMS interface.
· Perform system troubleshooting and escalate issues for resolution as necessary.
· Resolve deficiencies, inconsistencies and discrepancies in the documentation identified for change with the change owner; Modify file attachments, create change tasks, and change/add approvers if needed;
· Collaborates and communicates with other functions and PLM users as necessary for managing change control and to resolve issues related to the change order and provide guidance on the PLM process.
· Collaborate with Change Owners as necessary to identify audiences for training, including for new and revised documents; Verify and ensure that the proposed change is compiled, prepared, reviewed, approved, and trained to per established procedures and aligned with relevant regulations;
· Confirm all files are accessible and able to be opened and read and that resulting training records are available; Manage and prioritize site specific change orders and training assignments; Add PLM and LMS users for applicable sites; Support the creation and maintenance of change control procedures and training procedures as necessary; Provides PLM user and LMS user support and training as needed;
· Support internal and external audits, including but not limited to FDA inspections; Support the data collection and generation of reports; Support cross-functional global project teams to address business issues, including but not limited to asset relocation, label changes, etc.;
· Escalate PLM system and LMS issues as necessary for resolution; Follow-up with users and/or departments for compliance to the training quality system requirements; Assist in investigation to improve quality system processes; including audit observation and CAPA investigations; Perform other job-related duties as assigned.

Desired profile

Qualifications :

·  A Bachelor's degree is required a concentration in Life Science, Engineering, Physical Science, or a related area of study is preferred, combined with a minimum of 2 years of related experience within a regulated industry.
·  Evidence of managing projects which identify to positive, tangible business results is required.
·  Experience with Compliance wire or other learning management tools are preferred. Experience utilizing any PLM or electronic change control systems is preferred.
·  Excellent interpersonal, problem solving, detail oriented skills is required. Strong computer skills required. Strong proofreading, written and verbal communication skills are required. Ability to interface and collaborate with all levels of management and work with minimal supervision is required.
·  Analytical ability for metrics is required. Problem solving for issue resolution is required.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.

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.