Audit-Ready Quality Documentation Specialist

Scientific Search; Malvern (Chester County); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Competitive benefits

Bonus plan

Job summary

Scientific Search in Malvern, PA seeks a Quality Documentation Specialist to review and verify records, ensuring regulatory compliance and robust quality control throughout the documentation lifecycle.

You will maintain organized archives, support audits, drive process improvements, and collaborate with cross-functional teams to resolve issues and produce audit-ready documentation.

Qualifications

• Strong writing and organizational abilities required.
• Attention to detail essential for accurate documentation and record-keeping.
• Proficiency in research and technical understanding to ensure regulatory compliance.

Responsibilities

• Utilizes independent judgment to review, request, and approve documentation.
• Ensure documents meet regulatory standards, internal guidelines, and industry best practices.
• Support internal and external audits by ensuring documentation is audit-ready and compliant.
• Review, approve, and prepare Certificates of Analysis (COAs) in line with customer and regulatory requirements.
• Update and maintain documentation packages for consistency and accuracy.
• Fulfills customer document requests and uploads required documentation into customer systems.

Skills

Writing

Organizational skills

Attention to detail

Research skills

Communication skills

Project management basics

Problem solving

Education

Bachelor's degree

Tools

Microsoft Excel

Microsoft Office Suite

Job description

Overview

The Quality Documentation Specialist is responsible for reviewing and verifying documentation to ensure compliance with regulatory standards and internal quality control practices. The Quality Documentation Specialist will focus 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.

Overview

The Quality Documentation Specialist is responsible for reviewing and verifying documentation to ensure compliance with regulatory standards and internal quality control practices. The Quality Documentation Specialist will focus 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:The Quality Documentation Specialist is responsible for ensuring all documentation meets regulatory standards, internal quality guidelines, and industry best practices. The Quality Documentation Specialist will also support internal and external audits by ensuring documentation is audit-ready and compliant. Additionally, the specialist identifies and corrects documentation deficiencies, develops and improves documentation processes, and provides training to staff on document control procedures. Collaboration with cross-functional teams is essential to align documentation with organizational goals and resolve issues efficiently. The Quality Documentation Specialist also generates reports on document status, compliance issues, and process improvements, tracking key metrics to support continuous quality improvement.

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.
  
  

Work Experience Requirements

• 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, with demonstrated proficiency in Microsoft Excel (e.g., data tracking, basic formulas, and reporting) and Microsoft Office Suite (Word, Outlook, PowerPoint).
  
  

Education

• Bachelor’s degree preferred
  
  

The client offers a competitive salary package that is dependent on qualifications and experience, as well as a strong benefit package, plus participation in a company-wide bonus plan. For immediate consideration and faster response, please forward current resume to: [e-mail]. Please include job #20004 in subject line. Please note that all candidates applying must be a US Citizen or Permanent Resident. Client will NOT sponsor.