QA Documentation Specialist: Batch Records & Compliance

Ultimate Staffing; Allendale (NJ); On-site; USD 60,174,000 - 63,039,000; Full time

Benefits offered by this job

Permanent full-time role

Growth opportunities

Professional environment

Competitive pay

Job summary

Ultimate Staffing represents a growing manufacturing client in Mahwah, NJ, seeking a QA Documentation Specialist / Batch Record Reviewer to join the Quality team. The role focuses on GDP-compliant review of batch records, release of products, and maintaining accurate documentation in a GMP environment.

Ideal candidates have 3+ years of GMP experience, strong GDP/ALCOA+ knowledge, and the ability to manage multiple projects while coordinating with Production, Engineering, and Quality teams.

Qualifications

• Minimum 3 years of GMP experience in a manufacturing or regulated environment.
• Experience reviewing batch records and manufacturing documentation.
• Strong GDP and ALCOA+ data integrity knowledge.
• Ability to interpret drawings, specifications, quality records, and procedures.
• Excellent attention to detail and documentation accuracy.
• Proficient in MS Word and Excel.
• English communication skills and ability to work independently.

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 ALCOA+ data integrity principles.
• Identify and resolve discrepancies, missing information, and documentation errors prior to product release.
• Develop understanding of company products, components, and materials.
• Act as SME for documentation requirements and quality standards.
• Generate and issue Certificates of Conformance (COCs).
• Ensure certifications reflect product specs, inspection results, and standards.
• Verify supporting quality documentation is complete and approved before certification.
• Maintain release schedules and support multiple projects.
• Collaborate with Production, Engineering, and Quality departments.
• Support Quality Control activities and inspections as needed.
• Perform additional duties and special projects.

Skills

GMP experience

Attention to detail

Organizational skills

Communication skills

MS Word

MS Excel

Independent work

English proficiency

Education

High School Diploma or GED

Associate's degree preferred

Tools

Microsoft Word

Microsoft Excel

Job description

Ultimate Staffing represents a growing manufacturing client in Mahwah, NJ, seeking a QA Documentation Specialist / Batch Record Reviewer to join the Quality team. The role focuses on GDP-compliant review of batch records, release of products, and maintaining accurate documentation in a GMP environment.

Ideal candidates have 3+ years of GMP experience, strong GDP/ALCOA+ knowledge, and the ability to manage multiple projects while coordinating with Production, Engineering, and Quality teams.