KVK Tech, Inc. · 21 hours ago
QA Investigations / Technical Writer
Newtown, PA
Full-time
Onsite
Mid, Senior Level
3+ years expKVK Tech, Inc. is seeking an experienced QA Investigations / Technical Writer to join their team. This role is responsible for supporting site quality systems through the investigation of quality events and the development, review, and maintenance of controlled documentation in a pharmaceutical manufacturing environment.
ManufacturingMedical DevicePharmaceutical
Responsibilities
Investigate and document quality events including deviations, incidents, planned deviations, OOS investigations, and customer complaints
Perform and document root cause analyses and develop appropriate corrective and preventive actions (CAPAs) in alignment with regulatory expectations
Draft, revise, and maintain controlled documentation such as SOPs, batch records, qualification and validation protocols, technical reports, and risk assessments
Support change control activities related to manufacturing processes, equipment, facilities, and quality systems
Collaborate with Manufacturing, Packaging, Engineering, and Quality teams to ensure documentation accuracy and procedural alignment
Support continuous improvement initiatives through trend analysis, audit observations, and quality system enhancements
Qualification
Required
Bachelor's degree in a scientific or technical discipline such as Chemistry, Biology, Pharmacy, or Engineering required
Minimum 3–5+ years of experience in a pharmaceutical or regulated manufacturing environment
Demonstrated experience in technical writing, deviation and CAPA management, and change control systems
Working knowledge of cGMP requirements (21 CFR Parts 210/211) and FDA quality system expectations
Strong written communication, analytical, and organizational skills with a high attention to detail
Preferred
Master's degree
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