QA Associate

Intelliswift Software • Santa Clara, CA

104d

About The Position

The QA Associate position involves providing on-the-floor QA oversight and support to manufacturing operations. The role requires reviewing executed batch records and associated documents to ensure compliance with approved procedures and cGMP expectations. The QA Associate will respond to quality-related incidents or non-conformances on the floor and secure necessary documentation for real-time investigations. Additionally, the associate will represent QA in support of deviations, actively participating in Root Cause Analysis (RCA). The position also includes providing cGMP and compliance guidance to Manufacturing and Novato Technical Services (NTS) personnel, as well as authoring, reviewing, and approving documents in Quality Management Systems in accordance with company policies. The role requires performing area walkthroughs and other duties and projects as assigned by management. It is important to note that while this role primarily involves night and weekend shift hours, there may be occasions where flexibility is required, as shift hours can vary depending on operational demands.

Requirements

• Prior batch record execution or review experience
• Prior experience in investigation, change control, other Quality Management Systems (QMS)
• Working knowledge of cGMPs
• Excellent written and verbal communication and interpersonal skills
• Must display strong analytical and problem-solving skills

Nice To Haves

• Manufacturing and Manufacturing Sciences experience preferred

Responsibilities

• Provide on-the-floor QA oversight and support to manufacturing operations
• Review executed batch records and associated documents to ensure compliance with approved procedures and cGMP expectations
• Respond to quality-related incidents or non-conformances on the floor and secure necessary documentation for real-time investigations
• Represent QA in support of deviations including active participation in Root Cause Analysis (RCA)
• Provide cGMP and compliance guidance to Manufacturing and Novato Technical Services (NTS) personnel
• Provide QA support including authoring, review, and approval of documents in Quality Management Systems in accordance with company policies
• Perform area walkthroughs
• Perform other duties and projects as assigned by management

What This Job Offers

• Industry: Professional, Scientific, and Technical Services