Senior QA Associate

Senior QA Associate

KVK Tech is seeking a Senior QA Associate to join our team in Newtown, PA.

The Senior QA Associate will serve as a key Quality Systems subject matter expert (SME), supporting multiple core elements of the site Quality Management System (QMS), including deviations, investigations, CAPAs, change controls, complaints, document control, and quality event trending. This role acts as a cross‑functional QA partner to Manufacturing, Packaging, QC, and Engineering, ensuring that all quality records are accurate, compliant, and scientifically justified.

The ideal candidate will be a strong technical writer with deep QMS experience, capable of leading complex investigations, supporting audits and inspections, and driving continuous improvement across oral solid dosage operations.

• 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.

• 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 Master Control, Track Wise, or Veeva) and strong analytical and communication skills.

• 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

KVK Tech is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status.

We encourage you to apply if you feel that you are a match! We look forward to hearing from you.

Apply for this position

• Seniority level:
  Mid‑Senior level
• Employment type:
  
  Full‑time
• Job function:
  Quality Assurance
• Industry: Pharmaceutical Manufacturing