Quality Documentation Specialist

Scientific Search

Malvern, PAFresher54m agovia LinkedIn

About the Role

The Quality Documentation Specialist is responsible for reviewing and verifying documentation to ensure compliance with regulatory standards and internal quality control practices. The role focuses on maintaining accurate and organized record archives, conducting thorough reviews to ensure documentation is complete, accurate, and relevant, and supporting continuous improvement in documentation processes.

Job Function

  • Ensure all documentation meets regulatory standards, internal quality guidelines, and industry best practices.
  • Support internal and external audits by ensuring documentation is audit-ready and compliant.
  • Identify and correct documentation deficiencies.
  • Develop and improve documentation processes.
  • Provide training to staff on document control procedures.
  • Collaborate with cross-functional teams to align documentation with organizational goals and resolve issues efficiently.
  • Generate reports on document status, compliance issues, and process improvements, tracking key metrics to support continuous quality improvement.

Key Responsibilities

  • Utilizes independent judgment to initiate customer communication, request, review, and approve documentation.
  • Has authority to make decisions on requesting and approving documents from suppliers as they pertain to food safety, quality, legality, or product authenticity.
  • Serves as backup to the Quality Specialist.
  • Reviews, approves, and prepares Certificates of Analysis (COAs) in accordance with customer and regulatory requirements.
  • Reformats and maintains specification packages as necessary to ensure consistency and accuracy.
  • Fulfills customer document requests and uploads required documentation into customer systems (e.g., TraceGains, Safety Chain, or similar platforms).
  • Participates in mock recalls and traceability exercises as required.
  • Participates in department projects and process improvement initiatives; completes additional tasks as assigned.

Requirements & Tech Stack

  • Strong writing and organizational skills
  • Attention to detail
  • Proficiency in research and technical understanding
  • Effective communication abilities
  • Adaptability to industry changes
  • Basic project management skills
  • A knack for problem-solving.
  • Intermediate computer skills required.
  • Demonstrated proficiency in Microsoft Excel (e.g., data tracking, basic formulas, and reporting).
  • Demonstrated proficiency in Microsoft Office Suite (Word, Outlook, PowerPoint).

Qualifications

  • Bachelor’s degree preferred.
  • Must be a US Citizen or Permanent Resident.

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