Quality Control Technician

Performs functions associated with cGMP manufacturing operations within the drug product manufacturing and packaging facility, including performing visual inspection of both finished and in-process materials, verifying manufacturing data in the batch record system, and conducting testing on in-process materials. Uses sophisticated programs (such as POMS and SAP) to evaluate operating data, which can be used to determine acceptable quality limits and product release requirements.

Responsibilities

• Responsible to enter test results in manufacturing systems such SAP, POMS, and LIMS.
  Interprets experimental data for conformance with product and material specifications.
• Perform in-process laboratory tests such as Karl Fischer and Torque removal testing, as written per procedure
• Responsible for correct documentation and compliance with GDP requirements of the tasks performed.
• Performs visual inspection of finished and in-process materials, classifies defects, and determines test disposition
• Performs test methods as written to support product/material release.
  Reviews and verifies manufacturing operating settings.
• Makes suggestions for improvement based upon scientific and good manufacturing practices understanding.
• Understands and maintains a safe work environment for themselves and others in accordance with procedural requirements.
• Accepts responsibility for acquiring knowledge and experience to support continual personal development.
• Budget time effectively to carry out assigned tasks and takes initiative to be involved in team activities and decision making.
• Works with others to maintain a positive atmosphere to accomplish business objectives and is an active participant in the work structure and fosters positive working relationships with all levels of the organization