Job Description

Position Title: Associate, QA Frontline (Overnight)

Location: Novato, CA

Duration: 12 Months Contract on w2

Shift Details:

Alternate Wed, Thurs-Sat 6:00 PM – 7:00 AM

Alternate Wed, Sun-Tues 6:00 PM – 7:00 AM

Duties:

-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 *** policies

-Perform area walkthroughs

-Perform other duties and projects as assigned by management

Please note that while this role primarily involves night and weekend shift hours, there may be occasions where the need for flexibility is required, as shift hours can vary depending on operational demands.

-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

-Manufacturing and Manufacturing Sciences experience preferred