Johnson & Johnson Careers

Quality Specialist, Documentation

Irwindale, California
Quality Systems


Job Description

Requisition ID: 5251180919

Johnson & Johnson’s Cardiovascular & Specialty Solutions (CSS) Group within Medical Devices is recruiting for a Quality Specialist, Documentation for Biosense Webster located in Irwindale, CA.  The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Surgical and Non-Surgical Aesthetics, Neurovascular and Reprocessing.

 

Biosense Webster is the global leader in the science of diagnosing and treating heart rhythm disorders and one of the fastest-growing businesses within Johnson & Johnson.

 

The Quality Specialist, Documentation is position is responsible for planning, coordinating, executing an effective and efficient document change control process to ensure compliance with company and regulatory requirements.

 
DUTIES & RESPONSIBILITIES

Under (e.g. limited supervision, general direction, etc.) and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

                                                                          
  • Initiates and executes an effective and efficient change control process in accordance to internal and external requirements
  • Assists Documentation Supervisor with improvement and standardization of Document Change Control processes.
  • Maintains an effective change and version control of all documents.
  • Supports NPD pipeline projects
  • Investigates and resolve NCRs, Internal Audits, CAPAs related to Documentation Services 
  • Provides oversight/support of periodic document review process to drive timely completions.
  • Assists with reporting and analysis of Change Control metrics
  • Serves as PLM super user and train new associates or document owners in document management processes 
  • Follows all standard operating procedures
  • Performs other duties assigned as needed
  • Responsible for communicating business related issues or opportunities to next management level
  • Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
  • Performs other duties assigned as needed


Qualifications

QUALIFICATIONS:

  • A Bachelors degree and at least 2 years of relevant experience in Quality Systems  or Document Management in a regulated industry is required.
  • Knowledge of GDP, and FDA and ISO standards are required.   
  • Experience providing support for internal audits and inspections by regulatory authorities is preferred.
  • Experience with CAPA, NCR and internal audit process is preferred
  • Prior exposure to various functions of corporate organization and cross-functional experience is preferred
  • Experience working with product development and/or manufacturing is preferred   
  • Excellent interpersonal and communication skills are required
  • Excellent time management and problem-solving skills, and the ability to work in fast paced environment and rapidly shift priorities are required
  • Must be detail oriented and accurate and able to quickly adapt and navigate various technology and computer software.
  • Ability to communicate with multiple levels of management is required
  • Proficiency in Microsoft Office Applications, Adobe Acrobat, and some knowledge of database application is required.
  • The position is located in Irwindale, CA and may require approximately 10% travel (domestic & international).
 



Primary Location
United States-California-Irwindale-
Organization
Biosense Webster Inc. (6010)
Job Function
Quality Systems
Requisition ID
5251180919