Documentation Coordinator

2 weeks ago

Whitby, Canada Thermo Fisher Scientific Full time

Job Summary: Responsible for managing and maintaining a controlled document library, ensuring compliance with GMP regulations and company policies.

Job Description:

Responsible for receiving, filing, controlling, and retrieving executed GMP documents, including batch records and validation reports. Maintains the controlled document library, including routine filing and off-site storage. Manages the process for disposition of GMP documents, including shipment to clients or destruction of client and site documents. Supports compliance auditors in audit preparations, including document retrieval and assembly. Collaborates with cross-functional teams to reinforce site requirements.

Key Responsibilities:

  • Maintain accurate document database and archives.
  • Retrieve documents in a timely manner.
  • Enforce procedures governing document management and compliance requirements.
  • Manage access to the controlled document library, including removal and return of records stored within.
  • Support onsite customer and regulatory audits.
  • Receive, file, and retrieve documents.
  • Manage process for disposition of GMP documents that have reached their retention periods.
  • Prepare documentation for off-site storage.
  • Secure required documentation on time to maintain client deadlines.
  • Respond to regulatory, customer, or internal requests for document information.
  • Facilitate periodic review of controlled documents.
  • Maintain a safe working environment and report potential hazards.

Requirements:

Education:

High school diploma or equivalent required.

Experience:

No previous experience required.

Knowledge, Skills, and Abilities:

Organized and detail-oriented. Proficient in Microsoft Office products (Word, Excel, PowerPoint). Ability to work on multiple projects simultaneously. Excellent communication and interpersonal skills. Proficiency in the English language.

Standards and Expectations:

Follow all Environmental Health & Safety policies and procedures. Work collaboratively with fellow team members. Carry out all duties within strict compliance to company quality systems SOP's and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems. Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve performance by identifying areas for system improvements and engaging in problem-solving.

Physical Requirements:

Moderate physical effort and fatigue. Walks, sits, or stands for limited periods. May require recurring stretching or reaching. Regular movement of files, binders, and boxes of documentation to and from off-site storage. Climbing of ladder to reach upper shelves. May require occasional equipment operation. Lifts light items for limited duration.

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