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Manufacturing Documentation Specialist

The Documentation Specialist is an internal resource who ensures all production documentation complies with all relevant requirements – internal, customer, and regulatory. As a member of the APA team, the Documentation Specialist will liaise with Equipment Operators, Team Leads, and members of the Quality organization to ensure the production of high quality documentation.

Responsibilities

    • Assist with the editing of quality documents (SOPs, guidelines, validation master plans etc.) to ensure compliance with regulatory requirements.
    • Work closely with Operations leadership to identify areas to improve documentation – review current processes, tools, and methodologies with a critical towards improving and streamlining documentation processes and outputs.
    • Prepare and/or maintain documentation pertaining to programming, systems operation, and user documentation.
    • Provide internal guidance and training to Operations team on documentation requirements, processes, and SOPs.
    • Translate business specifications into user documentation – specifically ensuring all SOPs are clearly written and meet business requirements.
    • Track and review change control documentation.
    • Authors deviations and CAPAs for Manufacturing and participates and applies Root Cause Analysis (RCA) tools and ensures CAPAs are implemented to eliminate deviation re-occurrence
    • Plan, write, and maintain systems and user support documentation efforts to ensure RFT principles are applied across all Operations documentation.
    • Provide planning oversight to project team from new equipment introduction to commercial readiness.

Qualifications

    • Relevant degree/diploma is an asset
    • Must be able to work quickly with a high degree of accuracy.
    • Must possess sound interpersonal and information gathering skills, be able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others.
    • Proven experience reviewing manufacturing, engineering, or quality documentation
    • Demonstrated background authoring CAPAs and deviations in a GMP environment
    • Knowledge of FDA and HC regulatory requirements are an asset.
    • Experience with FAT/SAT/DQ/IQ/OQ

Application Process

Application process: Please send your resume using the form below.

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