Quality Documentation Review

Position OverviewWe are seeking a Quality Documentation Specialist to support batch release and quality review activities within a manufacturing environment. This role will be responsible for reviewing electronic batch records and related documentation to ensure accuracy, completeness, and compliance with quality requirements.The ideal candidate will have experience in quality systems, documentation review, or manufacturing support within a regulated environment.

Responsibilities

• Review electronic batch records and manufacturing documentation to support batch release activities.
• Ensure documentation is complete, accurate, and compliant with established procedures and quality standards.
• Support quality review activities across multiple manufacturing operations.
• Identify documentation issues, discrepancies, and follow-up actions as needed.
• Maintain accurate records and support quality documentation management processes.
• Collaborate with manufacturing, quality, and operational teams to resolve documentation-related issues.
• Support compliance, inspection readiness, and continuous improvement initiatives.
• Perform additional quality or administrative support activities as needed.

Required Qualifications

• Bachelor's degree in a scientific, technical, quality, or related discipline.
• Experience in quality assurance, document review, manufacturing support, or regulated operations.
• Strong attention to detail and ability to review documentation for accuracy and compliance.
• Excellent organizational and problem-solving skills.
• Ability to manage multiple priorities and meet deadlines.
• Strong written and verbal communication skills.
• Proficiency with electronic documentation systems and Microsoft Office applications.

Preferred Qualifications

• Experience reviewing electronic batch records.
• Experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Familiarity with GMP documentation practices and quality systems.
• Experience supporting batch release, production review, or quality operations.

Benefits

• Health coverage
• Life insurance
• Disability insurance
• 401k benefits