Batch Record Reviewer

Alan Baird Industries•Allendale, NJ

9d•$19 - $22•Onsite

About The Position

The Batch Record Reviewer is responsible for reviewing and releasing finished goods while ensuring all documentation meets Good Documentation Practices (GDP) and ALCOA+ data integrity principles. This role involves serving as a Subject Matter Expert (SME) for documentation requirements, developing a deep understanding of company products, and maintaining tight schedules for releases across different projects. The reviewer will also communicate effectively with Production, Engineering, and Quality teams and support Quality Control by performing inspections as needed.

Requirements

Strong understanding of GDP and ALCOA+ data integrity principles.
Ability to interpret drawings, specifications, and quality records.
Demonstrated ability or potential to develop product-level expertise (SME).
Strong attention to detail and documentation accuracy.
Ability to work as a self-starter.
Knowledge of Microsoft Excel and Word.
Strong interpersonal and communication skills.
Able to execute all duties and responsibilities in a safe and timely manner.
Ability to speak, read, and write in English.

Nice To Haves

Experience in Quality or related field
3-5 years of experience in GMP

Responsibilities

Review batch records and travelers for completeness, accuracy, and compliance.
Release product in accordance with internal procedures and quality standards.
Ensure all documentation adheres to GDP standards (legible, complete, properly corrected, and signed/date).
Confirm data integrity in alignment with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
Ensure discrepancies, missing data, or documentation errors are identified and resolved prior to release.
Develop deep understanding of company products including raw materials and components.
Serve as a Subject Matter Expert (SME) for documentation requirements.
Generate and issue Certificate of Conformance.
Ensure certifications accurately reflect product specifications, test/inspection results, and applicable standards.
Verify all supporting data is complete and approved prior to certification issuance.
Able to maintain tight schedules for releases for different projects.
Communicate effectively with Production, Engineering, and Quality teams regarding product status.
Support Quality Control by performing inspections as needed to verify product conformance.
Any other duties assigned by supervisor.