Associate, QA Frontline (Overnight) Job at Randstad Life Sciences in Novato

We are a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.

A high-level of initiative, energy, and motivation are key role requirements, as well as organizational skills and the ability to motivate others.

Shift: 
Alternate Wed, Thurs-Sat 6pm-7am
Alternate Wed, Sun-Tues 6pm-7am

Max PR: $40.27/hr

2 open positions; order 1 of 2

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 flexibilities required, as shift hours can varydepending on operational demands.  

Skills:

• 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 

Required

• BATCH RECORD REVIEW
• QA
• ROOT CAUSE ANALYSIS
• PROBLEM-SOLVING
• CGMP

Additional

• TECHNICAL SERVICES
• CGMPS
• REAL-TIME
• CHANGE CONTROL
• QMS
• DOCUMENTATION
• BATCH RECORD
• MANUFACTURING OPERATIONS
• EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS
• BATCH RECORDS

Education:

• BS/BA in a scientific discipline or related field and 3-5 years experience in a biologics manufacturing environment