Senior QA Associate (Oral Solid Dosage Form Exp. Required)

Job Description

Job Description

Senior QA Associate

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 Senior QA Associate supports KVK Tech’s Quality Management System (QMS) through execution, review, and oversight of key quality processes including deviations, CAPAs, change controls, complaint investigations, and document control activities. This role performs detailed investigations, authors controlled documents, conducts trend analyses, and ensures compliance with cGMP and FDA requirements for oral solid dosage (OSD) manufacturing. The Senior QA Associate also collaborates closely with Manufacturing, Packaging, Engineering, and QC to resolve quality issues, support operational compliance, and maintain inspection readiness across the site.

Key Responsibilities :

• Review, approve, and manage Quality Event Records—including Deviations, Investigations, CAPAs, Change Controls, and Customer Complaints—to ensure accuracy, completeness, and data integrity.
• Perform structured root cause analyses (5 Whys, Ishikawa, FMEA) and ensure development, implementation, and verification of effective CAPAs.
• Draft, revise, and review controlled documents, including SOPs, Work Instructions, batch records, risk assessments, qualification protocols, and technical reports.
• Conduct trend analysis for deviations, CAPAs, complaints, OOS / OOT events, and recurring quality issues to support continuous improvement initiatives and annual reporting.
• Review validation and qualification documents to ensure compliance with procedures, regulatory standards, and quality expectations.
• Evaluate change control requests for completeness, regulatory impact, cross-functional coordination, and justification alignment.
• Collaborate with Manufacturing, Packaging, Engineering, and QC to resolve documentation gaps, clarify processes, and ensure compliant execution of operations.
• Participate in internal audits, inspection readiness activities, and regulatory inspections by preparing documentation, providing SME-level support, and responding to auditor inquiries.
• Support training initiatives related to investigation writing, documentation expectations, and QMS processes.
• Contribute to continuous improvement efforts by identifying risk areas, recommending enhancements, and supporting implementation of quality system improvements.
• Perform additional duties as assigned to ensure robust QMS compliance and support organizational goals.

What We’re Looking For

Experience : 5–8 years of QA experience within a regulated pharmaceutical manufacturing environment, preferably oral solid dosage (OSD). Demonstrated expertise in deviation investigations, CAPA management, change control, complaint handling, and technical documentation is required.

Education : Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or related scientific discipline required; advanced degree preferred.

Skills & Knowledge :

What We Offer

Schedule

Full-time, on-site position with standard weekday business hours. Flexibility is required during audits, regulatory inspections, and high-priority quality events.

Company Description

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.

Company Description

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.