QA Documentation & Batch Records Specialist

Ultimate Staffing Services; Allendale (NJ); On-site; USD 41,000 - 50,000; Full time

Job summary

Ultimate Staffing Services is seeking a QA Documentation Specialist / Batch Record Reviewer for a growing manufacturing client in Mahwah, NJ. The role focuses on reviewing batch records, ensuring GDP compliance, and supporting product releases within a GMP-regulated environment.

Ideal candidates have 3+ years of GMP experience, strong attention to detail, and proficiency with Word/Excel. This is a permanent, full-time opportunity offering competitive pay and growth within Quality Operations.

Qualifications

• 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 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.
• Reading, writing, and communicating effectively in English.

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.
• Develop understanding of company products, components, and raw materials.
• Act as SME for documentation requirements and quality standards.
• Generate and issue Certificates of Conformance (COCs).
• Ensure certifications reflect product specifications, inspection results, and applicable standards.
• Verify 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.

Skills

GMP experience

Batch records review

GDP knowledge

ALCOA+ principles

Reading drawings/specs

Attention to detail

Organizational skills

Problem-solving

Communication

English proficiency

Education

High School Diploma

Associate degree or higher preferred

Tools

Microsoft Word

Microsoft Excel

Job description

Ultimate Staffing Services is seeking a QA Documentation Specialist / Batch Record Reviewer for a growing manufacturing client in Mahwah, NJ. The role focuses on reviewing batch records, ensuring GDP compliance, and supporting product releases within a GMP-regulated environment.

Ideal candidates have 3+ years of GMP experience, strong attention to detail, and proficiency with Word/Excel. This is a permanent, full-time opportunity offering competitive pay and growth within Quality Operations.