QA Investigator 10/14/22

KVK Tech is looking for a QA Investigator to join our team in Newtown PA

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

  1. Responsible for thoroughly investigating events as it relates to deviations and customer complaints communicated to or informed by QA and applying a science-based approach to accurately, correctly and timely document the final report utilizing appropriate investigation techniques and/or tools.
  2. Reviews and uses the established follow up mechanism to ensure that applicable investigations are initiated, timely completed, final reports issued and approved by QA.
  3. Evaluates and discusses the impact of the reported events to ensure that its effect on previously approved product has been considered as part of the investigation process and that actions are identified to prevent its recurrence.
  4. Reviews and evaluates each event under investigation against the applicable metrics defined/implemented to monitor the effectiveness of corrective and/or preventive actions and communicates results to site management on the established frequency or as agreed upon.

Benefits Include:

401(k) with matching

Health, Vision, Dental Insurance

Childcare Scholarship

Tuition Reimbursement

Bonus Pay + Merit Increases

Paid Time Off

Flexible Holidays

We are looking for applicants with:

  1. College Bachelor’s Degree in Natural Sciences, Pharmacy, or Engineering. Master degree is desirable, but not a must.
  2. Three to five years-experience in the pharmaceutical industry preferably with supervisory experience in the manufacturing, packaging, laboratory and/or Quality Assurance areas.
  3. Proficient knowledge of cGMP’s and FDA regulations.
  4. Knowledge of computer systems GMP requirements for Part 11 compliance
  5. Technical knowledge in pharmaceutical manufacturing processes, technologies, process validation and processing equipment.

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.