KVK Tech, Inc. · 1 month ago
Senior QA Associate
Newtown, PA
Full-time
Onsite
Senior Level
5+ years expKVK Tech, Inc. is seeking a Senior QA Associate to join their team in Newtown, PA. The Senior QA Associate will act as a key Quality Systems subject matter expert, supporting various elements of the site Quality Management System and ensuring compliance with quality records across operations.
ManufacturingMedical DevicePharmaceutical
Responsibilities
Review, approve, and manage deviations, investigations, CAPAs, change controls, and complaint records to ensure compliance with cGMP and data integrity expectations
Conduct structured root cause analyses and develop scientifically justified corrective and preventive actions
Author, revise, and review controlled documents, including SOPs, batch records, protocols, reports, and risk assessments
Perform trend analysis of key quality metrics to identify systemic issues and support continuous improvement initiatives
Provide QA support during internal audits, customer audits, and FDA inspections by preparing documentation and offering subject matter expertise
Collaborate across operations to resolve documentation issues and ensure compliant execution of quality-related activities
Support training efforts by assisting in the development and communication of investigation-writing and QMS best practices
Qualification
Required
Bachelor's degree in a scientific discipline such as Chemistry, Biology, Pharmaceutical Sciences, or Engineering
5–8 years of pharmaceutical QA experience, preferably within oral solid dosage manufacturing
Strong expertise in deviation investigations, CAPA management, change controls, and technical documentation
Advanced knowledge of cGMP, data integrity principles, and ICH guidelines
Proficiency with electronic QMS platforms (such as MasterControl, TrackWise, or Veeva) and strong analytical and communication skills
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