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PDS Tech Inc QA Auditor in Shawnee Mission, Kansas

PDS Tech is seeking candidates for a QA Auditor position in Lenexa, KS

The QA Auditor will audit product and document quality real time on the manufacturing line. In addition, the QA auditor will monitor the quality compliance in the media prep and aseptic filling areas. The QA Auditor position requires excellent attention to detail and organizational skills to ensure the accurate evaluation of product and documentation.

Key Responsibilities:

  • Review key attributes of production batch documentation online for accuracy and compliance with cGMP good documentation requirements.

  • Audit production batches according to ANSI AQL standards.

  • Communicate effectively and coordinate tasks with Manufacturing to ensure timely release of products.

  • Provide training to correct issues noted during DHR review

  • Monitor and coach aseptic practices

  • Provide aseptic gowning training

  • Audit 100% inspection rework activities

  • Support continuous improvement activities and participate in lean activities.

Minimum Requirements:

  • High School Diploma or equivalent.

  • Experience in manufacturing or laboratory setting.

  • Working knowledge of various computer software such as Excel.

  • Availability to work alternate shifts when needed.

Preferred Requirements:

  • 1+ years of experience in QA or QC within a regulated environment such as medical device, pharmaceutical, or food manufacturing.

  • Background in Medical device, cGMP, or ISO certified environment.

  • Data entry skills and familiarity with inventory management systems such as SAP.

  • Demonstrated ability to work effectively as a member of a cross-functional team.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.