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Associate, QA Frontline (Overnight)

Novato, CA 94949

Posted: 11/06/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 615601 Is job remote?: No Country: United States

Job Description

Shift Details: 
Alternate Wed, Thurs-Sat 1800-0700
Alternate Wed, Sun-Tues 1800-0700
 
-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 
 
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.  

Requirements:
-BS/BA in a scientific discipline or related field and 3-5 years experience in a biologics manufacturing environment 
-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
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About Novato, CA

Discover Exciting Job Opportunities in the Vibrant Novato, California Area! Novato, nestled in Marin County and conveniently located near San Francisco, offers job seekers a perfect blend of suburban charm and urban excitement. With its picturesque surroundings, proximity to the wine country, and access to stunning parks like Stafford Lake Park and the Marin Museum of Contemporary Art, Novato provides a dynamic backdrop for career growth. Enjoy the renowned cuisine at spots like Boca Tavern or trek the beautiful trails at Mount Burdell. Don't miss the Novato Theater Company productions or catch a game at the Novato Community Athletic Fields. Start your career journey in Novato today and experience the magic this bustling town has to offer.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.