KVK Tech, Inc. · 3 hours ago
QA Batch Record Reviewer – 2nd Shift
Newtown, PA
Full-time
Onsite
Entry Level
1+ years expKVK Tech, Inc. is seeking a 2nd Shift QA Batch Record Reviewer to join their team in Newtown, PA. The role involves reviewing executed packaging batch documentation to ensure accuracy, completeness, and compliance with cGMP requirements and internal quality standards.
ManufacturingMedical DevicePharmaceutical
Responsibilities
Review completed packaging batch records for oral solid dosage products to ensure compliance with approved master batch records, SOPs, and cGMP requirements
Verify documentation accuracy, including entries, calculations, reconciliations, signatures, initials, and dates, in accordance with data integrity (ALCOA+) principles
Review supporting documentation such as equipment logs, line clearance records, and component reconciliation records to ensure batch traceability and documentation consistency
Identify documentation discrepancies or errors and support deviation documentation and investigation activities as required
Track batch record review status and ensure proper routing, approval, and archival within electronic quality systems
Support inspection readiness by ensuring batch documentation is complete, accurate, and readily retrievable for internal and regulatory audits
Qualification
Required
High school diploma or equivalent required
1–3 years of experience in Quality Assurance, batch documentation review, or pharmaceutical manufacturing within a cGMP-regulated environment
Working knowledge of cGMP documentation practices and FDA regulatory expectations
Strong attention to detail with the ability to identify documentation discrepancies and compliance risks
Preferred
associate's degree or higher in a scientific, technical, or quality-related discipline
Proficiency with Microsoft Office and familiarity with electronic quality systems (e.g., MasterControl)
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
Company
KVK Tech, Inc.
KVK is a leader in the development and manufacture of high-quality, FDA-approved medicines that address unmet patient needs.
501-1000 employees
H1B Sponsorship
KVK Tech, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (18)
2023 (15)
2022 (27)
2021 (27)
2020 (28)
Funding
Current Stage
Late StageLeadership Team
A
Anthony Tabasso
President and CEO
Recent News
2026-01-01
Company data provided by crunchbase