Document Review Specialist

Document Review Specialist

The Document Reviewer Specialist is responsible for the timely review, verification, reconciliation, control, and administration of production, processing, quality, and regulatory documentation within Cayuga Milk's aseptic, ESL, and dairy ingredient manufacturing operations. This role serves as a critical member of the Quality Assurance team by ensuring all manufacturing and quality records are complete, accurate, compliant, and audit-ready prior to final quality review and product release.

Working closely with Production, Quality Assurance, Food Safety, Engineering, Maintenance, Laboratory, and Sanitation teams, the Document Reviewer Specialist maintains the integrity of the Quality Management System (QMS) through effective document control, batch record review, electronic records management, and regulatory compliance. This position supports compliance with FDA regulations, Grade "A" Pasteurized Milk Ordinance (PMO), Low Acid Canned Food (LACF) regulations (21 CFR Part 113), SQF Food Safety Code, HACCP, FSMA, GMPs, and company quality standards.

The Document Reviewer Specialist performs the detailed review and reconciliation of documentation; however, final product disposition and release authority remains with the Document Control Specialist, Quality Manager, or other designated Quality leadership.

Essential Duties & Responsibilities

Production Record Review & Verification

• Review Batch Production Records (BPRs), manufacturing records, packaging records, sanitation documentation, laboratory records, and quality documentation for completeness, accuracy, legibility, and compliance.
• Verify production documentation prior to product release review.
• Confirm all required signatures, initials, dates, timestamps, and verification activities are properly completed.
• Verify critical process parameters including: Time, Temperature, Pressure, Flow rates, Hold tube performance, Scheduled process requirements.
• Review aseptic processing documentation for compliance with FDA Low Acid Canned Food (21 CFR Part 113) regulations and Process Authority requirements.
• Compare production documentation against approved Master Manufacturing Records, scheduled processes, formulas, specifications, and work instructions.
• Identify missing documentation, calculation errors, omissions, deviations, or inconsistencies requiring correction.
• Collaborate with Production and QA personnel to resolve documentation discrepancies before records are finalized.
• Prepare complete documentation packages for Quality review prior to product disposition.

Document Control Administration

• Maintain the company's controlled document management system.
• Prepare, proofread, format, and process controlled documents.
• Maintain revision histories and document version control.
• Maintain Master Document Lists.
• Issue controlled documents throughout manufacturing departments.
• Remove obsolete documentation from circulation.
• Maintain document retention in accordance with company policy and regulatory requirements.
• Scan, file, organize, archive, and retrieve electronic and paper records.
• Support implementation and maintenance of Electronic Document Management Systems (EDMS).
• Ensure documents remain secure, confidential, and readily retrievable.

Quality Records Management

Maintain and review quality documentation including but not limited to:

• Batch Production Records
• Aseptic processing records
• Thermal processing records
• Laboratory testing records
• Environmental monitoring records
• Calibration records
• Preventive maintenance records
• Sanitation records
• CCP monitoring records
• HACCP records
• CAPA documentation
• Internal audit documentation
• Supplier approval records
• Product specifications
• Ingredient specifications
• Process Authority documentation
• Employee training records
• Validation and verification documentation
• Ensure all records are complete, accurate, legible, and retained according to company procedures.

Regulatory Compliance

Support compliance with:

• FDA Food Safety regulations
• 21 CFR Part 113 (Low Acid Canned Foods)
• Grade "A" Pasteurized Milk Ordinance (PMO)
• HACCP
• FSMA
• Current Good Manufacturing Practices (cGMPs)
• SQF Food Safety Code
• USDA requirements
• State regulatory agencies
• Customer-specific quality requirements
• Good Documentation Practices (GDP)
• ALCOA+ documentation principles

Audit Support

Provide documentation support during:

• SQF Certification Audits
• FDA inspections
• USDA inspections
• State regulatory inspections
• Customer audits
• Internal audits
• Third-party certification audits

Responsibilities include:

• Retrieving requested documentation
• Preparing audit files
• Organizing production records
• Reconciling documentation
• Supporting corrective action documentation
• Assisting with audit responses
• Ensuring records are inspection-ready

Continuous Improvement

• Track recurring documentation errors and trends.
• Recommend improvements to document control processes.
• Assist with development of standardized forms and templates.
• Support operator retraining through documentation trend analysis.
• Participate in continuous improvement initiatives related to documentation accuracy and compliance.
• Assist with implementation of electronic quality systems.
• Support special Quality and Operations projects.

Cross-Functional Collaboration

Work closely with:

• Production
• Quality Assurance
• Food Safety
• Laboratory
• Engineering
• Maintenance
• Sanitation
• Supply Chain
• Operations Leadership

to resolve documentation issues, investigate deviations, and improve documentation quality.

Qualifications

Education

Required

• Associate's degree in Food Science, Quality Assurance, Business Administration, Manufacturing Technology, or a related field.

Preferred

• Bachelor's degree in Food Science, Dairy Science, Quality Systems, Business Administration, or related discipline.

Equivalent combinations of education and experience may be considered.

Experience

Required:

• Minimum 2–3 years of experience in document control, quality assurance, manufacturing documentation, records management, or regulated manufacturing.

Preferred:

• Dairy manufacturing experience.
• Aseptic processing experience.
• Food manufacturing experience.
• Electronic Quality Management Systems (eQMS/EDMS).
• FDA-regulated manufacturing.
• Batch record review.
• Quality Management Systems.

Knowledge, Skills & Abilities

• Strong understanding of document control principles.
• Excellent organizational and time management skills.
• Exceptional attention to detail.
• Ability to identify documentation inconsistencies.
• Strong analytical and problem-solving skills.
• Ability to prioritize multiple tasks in a fast-paced manufacturing environment.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office Suite (Excel, Word, Outlook, SharePoint).
• Experience