QA Batch Record Reviewer (3-11:30pm; Pharma Exp. Required)

QA Batch Record ReviewerAbout KVK TechKVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer dedicated to developing and producing high-quality, FDA-approved medicines that improve patient lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech operates fully within the United States, ensuring quality and consistency through strict adherence to cGMP and regulatory requirements. Our commitment to excellence is rooted in precision, compliance, and a shared mission to provide affordable, life-improving pharmaceutical products.What You’ll DoThe QA Batch Record Reviewer is responsible for ensuring that all packaging and production documentation is complete, accurate, and compliant with cGMP standards and company procedures. This role provides critical oversight of documentation used to support product release, verifying that manufacturing and packaging processes are properly executed and recorded.Key Responsibilities:• Review completed batch production and packaging records for accuracy, completeness, and compliance with cGMP and SOP requirements.• Verify all signatures, initials, and dates for accuracy and ensure yields, reconciliations, and calculations are correct.• Check equipment logs, cleaning records, and material usage to confirm proper documentation and line clearance.• Identify and document any discrepancies, omissions, or deviations found during record review and communicate findings to QA management.• Track and maintain batch record review status within applicable quality systems or databases.• Support investigations, CAPAs, and deviation documentation by providing traceable source data as required.• Ensure all records adhere to FDA data integrity (ALCOA ) principles — accurate, legible, contemporaneous, original, and attributable.• Collaborate with cross-functional teams to drive improvements in documentation accuracy and efficiency.• Assist with authoring, reviewing, and processing controlled documents, SOPs, and validation protocols within MasterControl or other document management systems.• Maintain control and traceability of batch records throughout review, approval, and archival stages.• Perform additional QA duties as assigned to support department and site quality objectives.What We’re Looking ForExperience: 1–3 years of experience in Quality Assurance, documentation review, or manufacturing within a cGMP-regulated pharmaceutical or related environment preferred.Education: High school diploma or equivalent required; Associate degree or higher in Life Sciences, Chemistry, Biology, or a related technical discipline preferred.Skills & Knowledge:• Comprehensive understanding of cGMP documentation practices and FDA/ICH requirements.• Strong analytical skills with the ability to detect discrepancies and ensure compliance.• Proficiency in Microsoft Office (Word, Excel, Outlook) and familiarity with electronic quality systems such as MasterControl.• Excellent attention to detail, organization, and time management.• Effective written and verbal communication across functional teams.• Ability to manage multiple priorities and meet tight review deadlines with minimal supervision.• Commitment to quality, accuracy, and data integrity in all documentation activities.What We Offer• Competitive hourly rate with annual performance bonus eligibility• Annual merit-based pay increases• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed• Paid Time Off• 10 paid company holidays• Comprehensive medical, dental, vision, and life insurance coverage• Professional development reimbursement• Career growth opportunities• Tuition reimbursement for children and childcare expense reimbursementSchedule• Full-time, on-site position (3:00 pm - 11:30 pm)Company DescriptionKVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.

Salary : $25 - $30