Manufacturing Batch Record Reviewer

About the role

KVK Tech is seeking a Manufacturing Batch Record Reviewer to join our second-shift team in Newtown, PA. The Manufacturing Batch Record Reviewer will review completed batch records and supporting production documentation for oral solid dosage manufacturing. This role supports weighing and blending, encapsulation, compression, and coating operations by verifying documentation accuracy, coordinating corrections, and preparing completed record packages for Quality Assurance review. The ideal candidate will demonstrate strong attention to detail, organizational skills, and the ability to review written information and calculations accurately. Entry-level candidates are encouraged to apply.

Responsibilities

• Review completed manufacturing batch records, equipment and room logbooks, cleaning records, and supporting documentation for completeness, accuracy, and consistency.
• Verify required entries, dates, times, signatures, material information, lot numbers, equipment identification, and attachments against approved instructions and supporting records.
• Check calculations, yields, material reconciliations, and documented in-process results; identify and escalate discrepancies or results outside established limits.
• Coordinate documentation corrections and clarifications with responsible manufacturing personnel in accordance with approved procedures and data integrity requirements.
• Track record receipt, review progress, and outstanding corrections, and assemble completed record packages for transfer to Quality Assurance.
• Communicate potential process deviations, data integrity concerns, and product-quality issues to Manufacturing management and Quality Assurance.
• Provide backup packaging documentation review when trained and assigned, and retrieve records to support investigations, audits, and inspections.
• Identify recurring documentation errors and recommend improvements to forms, review practices, and training.

Qualifications

High school diploma or equivalent required; associate’s or bachelor’s degree in a scientific, technical, manufacturing, or related discipline preferred. 0–2 years of relevant experience in pharmaceutical manufacturing, packaging, batch record review, document control, or quality support preferred. Prior pharmaceutical experience is not required. Experience reviewing detailed records, verifying data accuracy, or maintaining documentation in a manufacturing, laboratory, or administrative setting is a plus. Familiarity with oral solid dosage manufacturing processes preferred, but not required.

Skills

• Strong attention to detail and proofreading skills, including the ability to identify missing entries, inconsistent information, and calculation errors.
• Ability to read and follow written procedures, operating instructions, and detailed production documentation.
• Basic mathematical proficiency, including arithmetic and percentages, with the ability to learn and verify yield calculations and material reconciliations.

Benefits

• 401(k) with company match
• Health, vision, and dental Insurance
• Childcare expense reimbursement
• Tuition reimbursement
• Annual bonus eligibility
• Annual merit increases
• Paid Time Off and Flexible Holidays