QA Documentation Specialist

About the Role

A growing manufacturing company in Mahwah, NJ is seeking a detail-oriented QA Documentation Specialist / Batch Record Reviewer to join their Quality team. This role ensures compliance with Good Documentation Practices (GDP), supports product releases, and maintains documentation accuracy in accordance with ALCOA+ data integrity principles. Ideal for candidates with GMP-regulated manufacturing experience who thrive in a fast-paced quality environment.

Responsibilities

• Review batch records, travelers, and manufacturing documentation for completeness, accuracy, and compliance.
• Release finished products in accordance with established quality procedures and standards.
• Ensure all documentation adheres to Good Documentation Practices (GDP), including proper corrections, signatures, dates, and legibility.
• Verify compliance with ALCOA+ data integrity principles.
• Identify and resolve discrepancies, missing information, and documentation errors prior to product release.
• Develop a thorough understanding of company products, components, and raw materials.
• Act as a Subject Matter Expert (SME) for documentation requirements and quality standards.
• Generate and issue Certificates of Conformance (COCs).
• Ensure certifications accurately reflect product specifications, inspection results, and applicable standards.
• Verify all supporting quality documentation is complete and approved before certification issuance.
• Maintain release schedules and support multiple projects simultaneously.
• Collaborate with Production, Engineering, and Quality departments regarding product status and documentation requirements.
• Support Quality Control activities and inspections as needed.
• Perform additional duties and special projects as assigned.

Requirements

• Minimum 3 years of GMP experience in a manufacturing, pharmaceutical, medical device, or regulated environment.
• Experience reviewing batch records, quality documentation, or manufacturing records.
• Strong understanding of Good Documentation Practices (GDP) and ALCOA+ principles.
• Ability to interpret drawings, specifications, quality records, and procedures.
• Strong attention to detail and commitment to documentation accuracy.
• Excellent organizational, problem-solving, and communication skills.
• Proficiency in Microsoft Word and Excel.
• Self-motivated with the ability to work independently and manage priorities effectively.
• Ability to read, write, and communicate effectively in English.

Qualifications

• High School Diploma or GED required.
• Associate's degree or higher preferred.
• Quality Assurance, Quality Control, Batch Record Review, or Documentation experience strongly preferred.
• Manufacturing experience in a regulated industry required.

Physical Requirements

• Ability to stand, walk, sit, bend, kneel, and move throughout the facility.
• Ability to lift and carry up to 35 pounds regularly and up to 50 pounds occasionally.
• Comfortable working in a manufacturing environment with varying noise levels and exposure to production equipment.

Benefits

• Permanent, full-time opportunity.
• Stable Monday-Friday schedule.
• Professional and collaborative work environment.
• Growth opportunities within Quality and Manufacturing Operations.
• Gain valuable experience with a respected manufacturing organization.

Pay

Competitive pay: $21.00-$22.00 per hour.