QA Document Coord., South Plainfield, 1st hift

About WestRock
WestRock (NYSE: WRK) partners with our customers to provide differentiated paper and packaging solutions that help them win in the marketplace. WestRock’s 50,000 team members support customers around the world from more than 320 operating and business locations spanning North America, South America, Europe, Asia and Australia. Learn more at www.westrock.com.

QA Document Coord., South Plainfield, 1st hift

6721-New Jersey


901 Durham Ave
South Plainfield, New Jersey, 07080
United States

GENERAL PURPOSE:  Maintain the document control system with responsibility to Westrock South Plainfield. Complete, distribute, implement, and maintain documents to define the basis of the quality and regulatory activities and processes. Coordinate document training utilizing QMS software.

 

ESSENTIAL JOB FUNCTIONS:

  • Responds to customer service requests and sales inquiries.

  • Manages and controls regulated documentation to meet cGMP and ISO9001 Quality Management System (QMS) requirements.  Documentation includes but is not limited to: SOP’s, work instructions, customer work instructions, protocols, and forms.

  • Monitors and tracks, through electronic media, the review, disposition, and approval of documents.

  • Assesses documents for suitability and compliance with QMS.

  • Manages all distribution of hard copy documents and maintains all quality document manuals, including retrieval of all obsolete documents. 

  • Provides overall leadership for documentation services at Westrock South Plainfield.

  • Coordinates and maintains document training records utilizing QMS software.

  • Provides training on the document control process/document training process and use of the software used to manage control of document/document training.

  • Interacts with employees and customers on a regular basis regarding systems and regulatory document control.

  • Supports Quality Management in the performance of document reviews, audits, and customer audit activities. 

  • Improves system/regulatory procedures to support the requirements of the Quality Management System. 

  • Performs other job duties as assigned.

     

     

    QUALIFICATIONS:

  • Have a minimum of 2 years’ experience in supporting the implementation of a Quality Management System or a combination of training and experience.
  • Must have prior experience writing Quality System documents.
  • Knowledge of documentation control requirements for the pharmaceutical and medical device industries preferred.
  • Must have intermediate PC skills including email, routine database activity, word processing, spreadsheets, graphics, etc.
  • Must have strong listening skills and be able to manage competing priorities.
  • Must understand basic math and be able to use a calculator.
  • Must possess the ability to coordinate and plan strategically.
  • Must be able to communicate effectively with co-workers, customers, and management.
  • Must be able to maintain good attendance.
  • Must be willing to work overtime as needed.
  • Must be able to perform all essential functions of this job with or without reasonable accommodation.

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