Job Description

Job Title: Quality Assurance Document Reviewer
Location: Round Lake, IL
Duration: 12+ Months
Experience: 3 5 Years

The Quality Assurance Document Reviewer will be responsible for reviewing, verifying, and maintaining quality documentation, both in paper and electronic formats. This role focuses on ensuring compliance with regulatory and quality standards by performing thorough document reviews, supporting quality operations, and assisting with process oversight. The position involves close collaboration with quality, production, and laboratory teams.

• Review, verify, and organize paper and electronic batch documentation for accuracy and completeness.

• Collect and assess production and quality records to ensure compliance with established procedures and regulatory standards.

• Perform in-depth assessments by gathering data through document review, employee interviews, and process evaluations.

• Identify risks and non-conformances in processes, systems, or documentation, and propose corrective action plans.

• Support audits and inspections by preparing documentation and resolving observations promptly.

• Write, review, and revise Standard Operating Procedures (SOPs) and other controlled documents to ensure compliance.

• Collaborate with production, quality, and engineering teams to improve processes and maintain high-quality standards.

• Participate in cross-functional quality improvement projects and continuous improvement initiatives.

• Serve as a subject matter resource for regulatory and compliance requirements related to quality control documentation.

• Bachelor's degree in Science, Engineering, or a related field (or equivalent experience).

• 3 5 years of experience in Quality Control or Quality Assurance, preferably within the medical device or pharmaceutical industry.

• Strong understanding of FDA regulations, Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP).

• Excellent attention to detail and strong organizational skills.

• Effective communication and interpersonal skills for collaboration across teams.

• Proven ability to manage multiple priorities in a fast-paced environment.

• Experience in batch record review and quality documentation processes.

• Proficiency with computer systems and document management tools.

• Experience working in a production or lab-based environment.

• Prior exposure to internal or external audits.

• Familiarity with quality management systems and documentation control.

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