Sr. Associate, Quality

6 months ago

Novato, United States BioMarin Pharmaceutical Inc. Full time

Who We Are

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

Senior Associate, Quality – On-Site Grave and Weekend Shift  Responsibilities: -Provide on-the-floor QA oversight and support to manufacturing operations -Review executed batch records and associated document 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 Manufacturing Sciences and Technology (MSAT) personnel -Provide QA support including write, review, and approve documents in Quality Management Systems in accordance with BioMarin policies -Perform area walkthroughs -Perform other duties and projects as assigned by management  Experience and Other Qualifications: -BS/BA in a scientific discipline or related field and 6-8 years experience in a biologics manufacturing environment -Prior batch record review experience is required -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 MSAT experience preferred  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.   Shift Details: Alternate Wed, Thurs-Sat 1800-0700 **We do provide Shift Differential pay for any off-hour shifts including Swing and Grave** No international travelling required. 

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

  • Sr. Associate, Quality

    6 months ago

    Novato, United States BioMarin Full time

    Who We Are BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and...

  • Quality Assurance Associate

    4 weeks ago

    Novato, California, United States TALENT Software Services Full time

    Job Summary: We are seeking a highly skilled Quality Assurance Associate to join our team at Talent Software Services. As a Frontline QA Specialist, you will be responsible for providing on-the-floor QA oversight and support to manufacturing operations. Your primary focus will be on reviewing executed batch records and associated documents to ensure...

  • Quality Compliance Associate

    2 weeks ago

    Novato, United States Meet Full time

    Job Summary: Meet's client is seeking a motivated and detail-oriented Quality Compliance Associate to support their Quality Compliance processes. This role is critical for ensuring inspection readiness, managing self-inspection programs, and enhancing data integrity initiatives. The Quality Compliance Associate will work closely with cross-functional teams...

  • Quality Compliance Associate

    2 weeks ago

    novato, United States Meet Full time

    Job Summary: Meet's client is seeking a motivated and detail-oriented Quality Compliance Associate to support their Quality Compliance processes. This role is critical for ensuring inspection readiness, managing self-inspection programs, and enhancing data integrity initiatives. The Quality Compliance Associate will work closely with cross-functional teams...

  • Senior Quality Associate

    3 weeks ago

    Novato, California, United States BioSpace, Inc. Full time

    Job Title: Senior Quality AssociateJob Summary: We are seeking a highly skilled Senior Quality Associate to join our team at BioSpace, Inc. The ideal candidate will have a strong background in quality assurance and control, with experience in biologics manufacturing.Responsibilities:Provide on-the-floor QA oversight and support to manufacturing...

  • Quality Assurance Associate

    3 weeks ago

    Novato, California, United States inSync Staffing Full time

    Job Summary:We are seeking a highly skilled Quality Assurance Associate to join our team at inSync Staffing. As a Quality Assurance Associate, you will be responsible for providing on-the-floor QA oversight and support to manufacturing operations.Key Responsibilities:Review executed batch records and associated documents to ensure compliance with approved...

  • Senior Quality Associate

    1 month ago

    Novato, California, United States BioMarin Full time

    Join BioMarin's Technical Operations team and contribute to the creation of life-changing drugs for patients worldwide. As a Senior Associate, Quality, you will play a critical role in ensuring the quality and compliance of our manufacturing processes and products.Responsibilities:Provide on-site quality oversight and support to manufacturing operations,...

  • Quality Assurance Associate

    3 weeks ago

    Novato, California, United States Intelliswift Full time

    Job Summary: We are seeking a highly skilled Quality Assurance Associate to join our team at Intelliswift. As a Frontline QA Specialist, you will be responsible for providing on-the-floor QA oversight and support to manufacturing operations.Key Responsibilities:Review executed batch records and associated documents to ensure compliance with approved...

  • Quality Assurance Associate

    4 weeks ago

    Novato, California, United States Randstad Life Sciences Full time

    Job OverviewWe are seeking a highly motivated and detail-oriented Quality Assurance Associate to join our team. As a Frontline QA Specialist, you will be responsible for providing on-the-floor QA oversight and support to manufacturing operations.Your key responsibilities will include reviewing executed batch records and associated documents to ensure...

  • Quality Compliance Associate

    3 weeks ago

    Novato, United States TalentBurst Full time

    Quality Compliance Associate Novato, CA, 94949 06 Months Description Support Quality Compliance processes including inspection readiness, self-inspection program, data integrity initiatives, and regulatory certification activities Support or lead continuous improvement in quality systems (procedures and systems) to improve organizational effectiveness,...

  • Quality Compliance Associate

    4 weeks ago

    Novato, United States R&D Partners Full time

    Biotechnology company is hiring a Quality Compliance Associate to support Quality Compliance processes including inspection readiness, self-inspection program, data integrity initiatives, and regulatory certification activities. This is a 6-month contract. ResponsibilitiesSupport or lead continuous improvement in quality systems (procedures and systems) to...

  • Quality Compliance Associate

    4 weeks ago

    novato, United States R&D Partners Full time

    Biotechnology company is hiring a Quality Compliance Associate to support Quality Compliance processes including inspection readiness, self-inspection program, data integrity initiatives, and regulatory certification activities. This is a 6-month contract. ResponsibilitiesSupport or lead continuous improvement in quality systems (procedures and systems) to...

  • Quality Compliance Associate

    4 weeks ago

    novato, United States R&D Partners Full time

    Biotechnology company is hiring a Quality Compliance Associate to support Quality Compliance processes including inspection readiness, self-inspection program, data integrity initiatives, and regulatory certification activities. This is a 6-month contract. ResponsibilitiesSupport or lead continuous improvement in quality systems (procedures and systems) to...

  • Quality Assurance Operations Associate

    4 weeks ago

    Novato, California, United States R&D Partners Full time

    Job DescriptionR&D Partners is seeking a Quality Assurance Operations Associate to provide quality oversight to support GMP Pharmaceuticals Manufacturing. This is a 4-month contract with a potential for extension.Responsibilities:Provide quality oversight of one or more portions of operations, including review of GMP documentation from manufacturing.Scanning...

  • Sr. Automation Engineer, Delta V

    6 months ago

    Novato, United States BioMarin Pharmaceutical Inc. Full time

    Who We Are BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and...

  • Sr. Automation Engineer, Delta V

    2 days ago

    Novato, United States BioMarin Pharmaceutical Full time

    Description Who We Are BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance...

  • External Quality Associate I

    6 months ago

    Novato, United States BioMarin Full time

    Who We Are BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and...

  • Quality Assurance Associate

    4 weeks ago

    Novato, California, United States R&D Partners Full time

    Job DescriptionWe are seeking a Quality Assurance Associate to provide on-the-floor oversight and support to our Manufacturing Operations team. This is a 12-month contract opportunity.Shift Options: Alternate Wed, Thurs-Sat 1800-0700 or Alternate Wed, Sun-Tues 1800-0700Key Responsibilities:Review executed batch records and associated documents to ensure...

  • Quality Assurance Specialist

    3 weeks ago

    Novato, California, United States Randstad Full time

    Quality Assurance (QA) Frontline AssociateJoin a global biotechnology company in Novato, CA, as a Quality Assurance (QA) Frontline Associate. This exciting opportunity is perfect for those looking to make a difference in the field of biotechnology.Job Summary:As a Quality Assurance (QA) Frontline Associate, you will provide on-the-floor QA oversight and...

  • Quality Compliance Specialist

    4 weeks ago

    Novato, California, United States Tucker Parker Smith Group (TPS Group) Full time

    Job Title: Quality Compliance AssociateLocation: Novato, CAAssignment: 7 Months (Great potential to extend)Pay Rate: $34/hrThe Tucker Parker Smith Group (TPS Group) is seeking a Quality Compliance Associate to support quality compliance processes and ensure adherence to regulatory standards. This temporary position, located in Novato, CA, will involve...