KVK Tech is looking for a QA Manager to join our team in Newtown PA.
This position’s responsibilities include, but are not limited to:
- Design, implement and manage the installation and use of Master Control to handle the electronic documentation of Market Complaint, Deviation, OOS, Outliers, Root Cause Investigation, CAPAs, Recall, Change Controls, SOP and training.
- Chair the Investigations review Board (IRB) meetings, issue minutes and follow up on corrective and preventative actions.
- Manage and trend the deviation process while ensuring that a thorough investigation report is completed in a timely manner using proven root cause analysis tools.
- Manage the review, tracking, GMP compliance and approval of Change Controls for Production Processes, Facilities and Equipment.
- Manage all CAPA commitments to ensure timely completion of the outlined tasks and effectiveness.
- Manage the Customer Complaint system for both product and adverse event complaints; ensuring investigations are performed on time and any notifications meet regulatory reporting requirements (i.e. Field Alert Reports (FARs), 3 day and 15 day alerts, etc.).
401(k) with matching
Health, Vision, Dental Insurance
Bonus Pay + Merit Increases
Paid Time Off
We are looking for applicants with:
- BS Chemistry or related science field, MS preferred
- 10 years of experience in the pharmaceutical industry preferred
- Good written and oral communication skills
- Experience in statistical analysis, process capability reviews with software preferred
- Ability to act independently
- Excellent interpersonal, verbal and written communication skills
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.