Sr. Documentation Coordinator

Job Summary:

• The Senior Documentation Coordinator is responsible to provide product quality support to Client (Raritan NJ) in support of product manufacture, validation, product-related projects and investigations.
• Ensure quality systems activities and site projects are executed in compliance Client policies and procedures and applicable regulations and standards (e.g. QSR, CMDR and other international regulations per product, ISO 13485 standard, 21 CFR 200's).
• Responsible for communicating and elevating critical business related issues as well as opportunities to management.

% of Time Tasks/Duties/Responsibilities:

• 40% Manage the distribution of product Certificates of Analysis, which includes:
  • Preparation of CofA’s.
  • Assembly of appropriate documents.
  • Distribution to affiliates in a timely manner.
  • Submission of CofA’s via the appropriate application.
• 25% Coordinate printing/receipt of all records into the department, which includes:
  • Logging into the database.
  • Stamping records.
  • Creating lot files.
  • Filing appropriately (into correct product files).
  • Review batch records.
  • Retrieval of records for FDA or other audits.
• 10% Input batch record errors into Lot Tracking spreadsheet daily.
• 10% Maintain all controlled documentation policies and procedures that apply to department; process changes as required.
• 15% Archive department records according to current company policies.
• Perform other work-related duties as assigned.

Other Duties:

• Provide internal and external audit support.
• Make decisions on the management of workflow to meet production deadlines.

Qualifications:

• High School Diploma.
• Minimum Years of Related Knowledge.
• A minimum of 3 years of overall experience in a quality environment is required.