Randstad
Quality assurance (qa) frontline associate - 3rd shift, 4x10
Randstad, Novato, California, United States, 94949
job summary:Immediate opportunity for a Quality Assurance (QA) Frontline Associate working with a global biotechnology company located in Novato, CA
If you're looking for an exciting opportunity to make a difference with an established company, that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health, we invite you to apply today!
Position Type:
1 year contract (through Oct. 2025)
Schedule/Shift:
3rd shift, 4x10 schedule
Thurs-Sat and alternate Wed, 6pm-7amSun-Tues and alternate Wed, 6pm-7amlocation: Novato, Californiajob type: Contractsalary: $34.23 - 40.27 per hourwork hours: 9 to 5education: Bachelors
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
BATCH RECORD REVIEWQAROOT CAUSE ANALYSISPROBLEM-SOLVINGCGMPAdditional
TECHNICAL SERVICESCGMPSREAL-TIMECHANGE CONTROLQMSDOCUMENTATIONBATCH RECORDMANUFACTURING OPERATIONSEXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLSBATCH RECORDS
skills: Quality Assurance, GMP (Good Manufacturing Practice), Manufacturing Operations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
If you're looking for an exciting opportunity to make a difference with an established company, that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health, we invite you to apply today!
Position Type:
1 year contract (through Oct. 2025)
Schedule/Shift:
3rd shift, 4x10 schedule
Thurs-Sat and alternate Wed, 6pm-7amSun-Tues and alternate Wed, 6pm-7amlocation: Novato, Californiajob type: Contractsalary: $34.23 - 40.27 per hourwork hours: 9 to 5education: Bachelors
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
BATCH RECORD REVIEWQAROOT CAUSE ANALYSISPROBLEM-SOLVINGCGMPAdditional
TECHNICAL SERVICESCGMPSREAL-TIMECHANGE CONTROLQMSDOCUMENTATIONBATCH RECORDMANUFACTURING OPERATIONSEXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLSBATCH RECORDS
skills: Quality Assurance, GMP (Good Manufacturing Practice), Manufacturing Operations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.