QA Monitor – 2nd Shift

KVK Tech is seeking a detail-oriented QA Monitor to join our team in Newtown, PA.

The QA Monitor plays a critical role in ensuring that all cleaning, sanitation, and line clearance activities are performed in strict alignment with cGMP, internal SOPs, and FDA expectations. This position provides continuous on-floor QA oversight to verify equipment readiness, prevent cross-contamination risks, and reinforce a culture of compliance, data integrity, and operational excellence. The ideal candidate will demonstrate strong attention to detail, comfort working in a regulated manufacturing environment, and the ability to collaborate closely with Production, QA, and Facilities teams.

This position’s responsibilities will include, but not be limited to the following:

  • Perform independent visual verification of room, equipment, and utensil cleaning prior to use and document results on approved QA monitoring forms.
  • Verify that cleaning logs, line clearance forms, and housekeeping records are completed accurately, legibly, and in accordance with cGMP and SOP requirements.
  • Conduct routine on-floor monitoring of cleaning and sanitation practices to ensure proper methods, detergent usage, and equipment labeling are followed.
  • Inspect and confirm compliance with “Cleaned” and “To Be Cleaned” status tags across manufacturing and packaging areas.
  • Observe line clearance activities to ensure complete removal of prior product, components, and documents before batch startup.
  • Report, document, and escalate any nonconformance, residue, or GMP deviation identified during monitoring.

We are looking for applicants with:

  • High School Diploma or equivalent required; Associate degree in Life Sciences or a related technical field preferred.
  • 0–2 years of experience in a cGMP pharmaceutical or manufacturing environment preferred; experience with cleaning, sanitation, or QA monitoring is a plus.
  • Working knowledge of cGMP cleaning and line clearance requirements.
  • Ability to interpret, complete, and review QA and cleaning documentation with accuracy and attention to detail.
  • Strong observational skills with the ability to identify residue, labeling discrepancies, or noncompliant cleaning practices.

What we offer:

  • 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.