QA Frontline Specialist

1 week ago


Novato, California, United States Intelliswift Software Inc Full time

**Job Overview**

We are looking for a highly motivated and detail-oriented QA Frontline Specialist to join our team at Intelliswift Software Inc. As a QA Frontline Specialist, you will be responsible for providing quality oversight and support to manufacturing operations.

The ideal candidate will have prior experience in investigation, change control, and other Quality Management Systems (QMS). You will also possess excellent written and verbal communication and interpersonal skills, as well as strong analytical and problem-solving abilities.

In this role, you will review executed batch records and associated documents to ensure compliance with approved procedures and cGMP expectations. You will also respond to quality-related incidents or non-conformances on the floor and secure necessary documentation for real-time investigations.

You will represent QA in support of deviations, including active participation in Root Cause Analysis (RCA). Additionally, you will provide cGMP and compliance guidance to Manufacturing and Novato Technical Services (NTS) personnel.

Key Responsibilities:

  • Provide quality oversight and support to manufacturing operations
  • Review executed batch records and associated documents
  • Respond to quality-related incidents or non-conformances
  • Represent QA in support of deviations
  • Provide cGMP and compliance guidance

Preferred Qualifications:

  • Prior experience in investigation, change control, and other QMS
  • Excellent written and verbal communication and interpersonal skills
  • Strong analytical and problem-solving abilities


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