QA Documentation Specialist - GDP & Batch Records Expert

Ultimate Staffing; Allendale (NJ); On-site; USD 29,000 - 30,000; Full time

Job summary

Ultimate Staffing is assisting a growing manufacturing client in Mahwah, NJ, seeking a detail‑oriented QA Documentation Specialist / Batch Record Reviewer to join the Quality team. You will review batch records, GDP compliance, and support product releases.

With GMP‑regulated experience, you will ensure ALCOA+ data integrity, generate Certificates of Conformance, and maintain documentation accuracy while coordinating with Production, Engineering, and Quality.

Qualifications

• GMP experience in a manufacturing or regulated environment.
• Strong GDP and ALCOA+ data integrity knowledge.
• Ability to interpret drawings, specifications, quality records, and procedures.
• Excellent organizational, problem-solving, and communication skills.
• Proficiency in Microsoft Word and Excel.

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 GDP, including 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.
• Collaborate with Production, Engineering, and Quality departments regarding product status and documentation requirements.
• Support Quality Control activities and inspections as needed.

Skills

GMP Experience

GDP & ALCOA+ Knowledge

Documentation Review

Attention to Detail

Communication Skills

Education

High School Diploma or GED

Associate's degree or higher preferred

Quality Assurance/Quality Control/Documentation experience preferred

Tools

Microsoft Word

Microsoft Excel

Job description

Ultimate Staffing is assisting a growing manufacturing client in Mahwah, NJ, seeking a detail‑oriented QA Documentation Specialist / Batch Record Reviewer to join the Quality team. You will review batch records, GDP compliance, and support product releases.

With GMP‑regulated experience, you will ensure ALCOA+ data integrity, generate Certificates of Conformance, and maintain documentation accuracy while coordinating with Production, Engineering, and Quality.