Batch Record Reviewer

Job Title : Batch Record Data Reviewer Location : Rensselaer, NY (Onsite) Employment Type : Contract (W2 ) About the Role We are seeking an experienced Batch Record Data Reviewer to support batch release and backlog reduction initiatives within a GMP-regulated API manufacturing environment. This role will focus on detailed batch record review, manufacturing documentation review, and data review activities to identify quality issues earlier in the release cycle and help accelerate batch disposition timelines. The ideal candidate will have strong API manufacturing experience, excellent GMP documentation knowledge, and the ability to independently review large volumes of documentation while maintaining accuracy and compliance. Key Responsibilities • Perform detailed batch record review and data review activities in support of batch release • Review manufacturing batch records, production documentation, and supporting GMP records for completeness and compliance • Identify documentation discrepancies, missing information, data integrity concerns, and potential investigation triggers • Escalate quality observations and documentation issues to QA, Manufacturing, QC, and Investigation teams • Support timely resolution of batch record comments and documentation corrections • Monitor recurring documentation issues and support process improvements • Ensure compliance with GMP documentation practices and data integrity requirements • Collaborate with cross-functional teams to support release timelines and backlog reduction efforts Required Qualifications • Hands-on experience within API Manufacturing environments • Experience with GMP batch record review, manufacturing documentation review, or QA/QC data review • Strong understanding of GMP regulations, GDP practices, and data integrity principles • Experience identifying documentation discrepancies and quality events • Familiarity with batch release and batch disposition processes • Strong attention to detail and ability to review high volumes of documentation accurately • Excellent communication and collaboration skills • Ability to work independently and take ownership of assigned review activities Preferred Qualifications • Experience with TrackWise, eQMS, MES, LIMS, ERP, or similar GMP systems • Experience supporting pharmaceutical manufacturing operations • Prior experience with deviation investigations and quality event management • Experience supporting batch release acceleration or documentation backlog reduction projects Salary Compensation is based on experience. Benefits This is a contract position and does not include employer-provided benefits. Equal Opportunity Employer We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Background Check Background checks may be conducted in accordance with applicable laws. Work Authorization Applicants must be authorized to work in the United States.