QA Documentation Sepcialist

Our client, 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 is responsible for reviewing batch records, ensuring compliance with Good Documentation Practices (GDP), supporting product releases, and maintaining documentation accuracy in accordance with ALCOA+ data integrity principles.

This is an excellent opportunity for candidates with GMP-regulated manufacturing experience who thrive in a fast-paced quality environment and have a passion for documentation accuracy and compliance.

Key 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.

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 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.

Education & Experience

• 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.

Why Join Us?

• Permanent, full-time opportunity
• Stable Monday-Friday schedule
• Competitive pay: $21.00-$22.00 per hour
• Professional and collaborative work environment
• Growth opportunities within Quality and Manufacturing Operations
• Gain valuable experience with a respected manufacturing organization

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All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.