Randstad Life Sciences US
Quality Assurance (QA) Frontline Associate - 3rd shift, 4x10
Randstad Life Sciences US, Novato, California, United States, 94949
Immediate opportunity for a Quality Assurance (QA) Frontline Associate working with a global biotechnology company located in Novato, CA.Position Type:
1 year contract (through Oct. 2025)Schedule/Shift:
3rd shift, 4x10 scheduleThurs-Sat and alternate Wed, 6pm-7amSun-Tues and alternate Wed, 6pm-7amEssential Duties and Responsibilities:Provide on-the-floor QA oversight and support to manufacturing operationsReview executed batch records and associated documents to ensure compliance with approved procedures and cGMP expectationsRespond to quality-related incidents or non-conformances on the floor and secure necessary documentation for real-time investigationsRepresent 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) personnelProvide QA support including authoring, review, and approval of documents in Quality Management Systems in accordance with company policiesPerform area walkthroughsPerform other duties and projects as assigned by managementPlease 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.Qualifications:Bachelor's degree (BS / BA) in a Scientific discipline or related fieldThree (3) - five (5) years' experience in a biologics manufacturing environmentPrior batch record execution or review experiencePrior experience in investigation, change control, other Quality Management Systems (QMS)Working knowledge of cGMPsExcellent written and verbal communication and interpersonal skillsMust display strong analytical and problem-solving skillsManufacturing and Manufacturing Sciences experience preferredRequired Skills:Batch Record ReviewQARoot Cause AnalysisProblem SolvingcGMPPreferred Skills and Experience:Technical ServicescGMPsReal-TimeChange ControlQuality Management System (QMS)DocumentationBatch RecordManufacturing OperationsExcellent Written and Verbal communication skillsBatch Records
1 year contract (through Oct. 2025)Schedule/Shift:
3rd shift, 4x10 scheduleThurs-Sat and alternate Wed, 6pm-7amSun-Tues and alternate Wed, 6pm-7amEssential Duties and Responsibilities:Provide on-the-floor QA oversight and support to manufacturing operationsReview executed batch records and associated documents to ensure compliance with approved procedures and cGMP expectationsRespond to quality-related incidents or non-conformances on the floor and secure necessary documentation for real-time investigationsRepresent 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) personnelProvide QA support including authoring, review, and approval of documents in Quality Management Systems in accordance with company policiesPerform area walkthroughsPerform other duties and projects as assigned by managementPlease 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.Qualifications:Bachelor's degree (BS / BA) in a Scientific discipline or related fieldThree (3) - five (5) years' experience in a biologics manufacturing environmentPrior batch record execution or review experiencePrior experience in investigation, change control, other Quality Management Systems (QMS)Working knowledge of cGMPsExcellent written and verbal communication and interpersonal skillsMust display strong analytical and problem-solving skillsManufacturing and Manufacturing Sciences experience preferredRequired Skills:Batch Record ReviewQARoot Cause AnalysisProblem SolvingcGMPPreferred Skills and Experience:Technical ServicescGMPsReal-TimeChange ControlQuality Management System (QMS)DocumentationBatch RecordManufacturing OperationsExcellent Written and Verbal communication skillsBatch Records