Visual Inspection Manager

1 week ago

Washington, Washington, D.C., United States Civica Rx Full time
About Civica Rx

Civica Rx is a leading social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our team of experienced healthcare and pharmaceutical industry leaders is committed to ensuring that quality generic medications are accessible and affordable to everyone.

We have established partnerships with over 55 health systems, representing over 1,500 hospitals and one-third of all U.S. hospital beds. Our organization has also begun to supply the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines.

Job Summary

The Manager, Visual Inspection is a key leadership role responsible for the management of the manual and automated Visual Inspection program at Civica Rx. This includes defect library, knapp test kits, AQL strategy, and inspection qualification. The successful candidate will be a subject matter expert for the visual inspection equipment/process and will perform various duties related to maintaining compliance and the continuous improvement of the visual inspection program.

Key Responsibilities
  • Partner with Technical Services, Quality, Manufacturing, and Engineering leadership to deliver functionally strong and operationally centered results.
  • Develop and maintain metrics to measure performance against business objectives and make necessary changes to improve performance.
  • Ensure that the Visual Inspection Program operates to meet the requirements of approved production plans at minimum costs within established quality limits and in accordance with FDA, cGMP, ISO, and OSHA requirements.
  • Mentor, coach, and develop the Visual Inspection Team to ensure timely completion of projects at the expected results.
  • Identify corrective and preventive actions (CAPA), lead project to completion within project timelines, and verify effectiveness of CAPA by post-project data collection and analysis.
Requirements
  • Advanced knowledge of Current Good Manufacturing Practices (cGMP), FDA, USP, OSHA, EPA, DEA, and other regulatory requirements.
  • Advanced knowledge of Visual inspection principles, practices, and applications.
  • Knowledge of Lean Six Sigma Tools and DMAIC problem-solving approaches.
  • Demonstrated excellence in oral and written communication.
  • 7+ years demonstrated ability in a GMP FDA, cGMP, ISO, or other regulated production environments.
  • At least 3 years previous management or leadership experience, including leading or working effectively with a cross-functional group.
  • Bachelor's degree in a science-related field; equivalent education and experience may be considered.

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