QA Inspector (2nd Shift 3-11:30pm; Pharma Experience Required)

QA Inspector

About KVK Tech

KVK 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.

What You’ll Do

The QA Inspector is responsible for performing in-process and final inspections on the production and packaging floors to ensure products meet quality standards and regulatory requirements. This position provides real-time quality oversight, ensuring all operations comply with established procedures, documentation practices, and data integrity expectations.

Key Responsibilities:
• Perform in-process inspections, component verifications, and line clearances in accordance with approved SOPs and batch records.
• Monitor manufacturing and packaging operations to ensure adherence to cGMP and internal quality procedures.
• Inspect raw materials, in-process samples, finished products, and labeling to verify conformance with specifications.
• Review batch production, cleaning, and packaging records for accuracy, completeness, and compliance prior to QA release.
• Document inspection results, deviations, and nonconformances accurately and contemporaneously.
• Assist with deviation investigations, CAPAs, and quality event documentation under QA management direction.
• Support audits, internal inspections, and continuous improvement initiatives.
• Collaborate closely with Production, Engineering, and Quality departments to address quality concerns promptly.
• Maintain data integrity and ensure documentation meets ALCOA+ principles at all times.
• Perform other related QA responsibilities as required to meet departmental objectives.

What We’re Looking For

Experience: 1–3 years of Quality Assurance or Quality Control experience in a GMP-regulated pharmaceutical, biotechnology, or related manufacturing environment.

Education: High school diploma or equivalent required; Associate degree or coursework in Life Sciences, Chemistry, or a related discipline preferred.

Skills & Knowledge:
• Strong understanding of current Good Manufacturing Practices (cGMP) and FDA compliance requirements.
• Knowledge of quality inspection techniques, sampling methods, and documentation review.
• Experience with batch record review, line clearance, or in-process inspection preferred.
• High attention to detail with the ability to detect and resolve nonconformances.
• Proficiency in Microsoft Office (Word, Excel, Outlook) and standard documentation systems.
• Excellent written and verbal communication skills; able to interact effectively across teams.
• Strong time-management, organization, and follow-through abilities.
• Ability to work independently while maintaining a high standard of accuracy and accountability.

What We Offer

• Competitive compensation 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
• Career growth opportunities
• Professional development reimbursement
• Tuition reimbursement for children and childcare expense reimbursement

Schedule

• Full-time, on-site position (3:00 pm - 11:30 pm); flexibility for off-shift or weekend support as business needs require)