Senior Quality Assurance Specialist

4 weeks ago


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

BioSpace, Inc.'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 BioSpace, Inc.'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.

Responsibilities:
  • 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 Manufacturing Sciences and Technology (MSAT) personnel
  • Provide QA support including write, review, and approve documents in Quality Management Systems in accordance with BioSpace, Inc. 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.

No international travelling required.

Equal Opportunity Employer/Veterans/Disabled



  • Novato, California, United States Planet Pharma Full time

    Quality Assurance SpecialistAt Planet Pharma, we are seeking a highly skilled Quality Assurance Specialist to support our Quality Compliance processes. The ideal candidate will have a strong background in biologics manufacturing and a proven track record of ensuring compliance with regulatory guidelines.Key Responsibilities:Support Quality Compliance...


  • Novato, California, United States Randstad Full time

    **Quality Assurance Specialist**We are seeking a highly skilled Quality Assurance Specialist to join our team at Randstad. As a Quality Assurance Specialist, you will be responsible for providing on-the-floor QA oversight and support to manufacturing operations. This includes reviewing executed batch records and associated documents to ensure compliance with...


  • Novato, California, United States Innova Solutions Full time

    Innova Solutions is seeking a highly skilled Quality Assurance Specialist to join our team.Job Summary:We are looking for a detail-oriented and organized individual to provide quality oversight of our manufacturing operations. The successful candidate will be responsible for ensuring adherence to Good Manufacturing Practices (GMP) and regulatory...


  • Novato, California, United States Randstad Life Sciences US Full time

    Job Overview:We are seeking a motivated Quality Assurance Specialist to join our team at Randstad Life Sciences US.Main 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...


  • Novato, California, United States PSG Global Solutions Careers Full time

    Job SummaryWe are seeking a skilled Quality Assurance Document Control Specialist to join our team at PSG Global Solutions Careers. As a Quality Assurance Document Control Specialist, you will be responsible for managing various internal documents while ensuring their accuracy, quality, and integrity.Responsibilities: Receive, review, edit, format, update,...


  • Novato, California, United States BioMarin Full time

    About the RoleBioMarin'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. We are seeking a Quality Assurance Specialist to support Quality Systems related to operations, product specification change controls and batch release processes.Key...


  • Novato, California, United States Joby Aviation Full time

    Job Summary:Joby Aviation is seeking a highly organized and detail-oriented Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will be responsible for performing incoming, in-process, and final inspections of composite materials and parts for our VTOL electric aircraft. Key Responsibilities: Participate in the...


  • 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...


  • 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...


  • Novato, California, United States Oakmont Senior Living Full time

    Job Summary: We are seeking a highly skilled and compassionate Senior Hospitality Specialist to join our team at Oakmont Senior Living. As a key member of our community, you will be responsible for providing exceptional customer service to our residents, guests, and visitors. Your primary focus will be on ensuring a safe and secure environment, managing...


  • 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...


  • 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...


  • 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...


  • 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...


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

    R&D Partners is seeking a Quality Compliance Specialist to support Quality Compliance processes, including inspection readiness, self-inspection program, data integrity initiatives, and regulatory certification activities. This is a 6-month contract with R&D Partners, a global functional service provider and strategic staffing resource specializing in...


  • Novato, California, United States Ultragenyx Full time

    Why Choose Ultragenyx?At Ultragenyx, we believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. Our vision is to lead the future of rare disease medicine by challenging the status quo and creating a new model that advances our field. We follow the science, apply a novel rapid development...


  • 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...


  • Novato, California, United States Intelliswift Software Inc Full time

    Job Description:Title: Quality System ManagerLocation: Not specifiedDuration: Not specifiedJob Summary:The Quality Systems Technical Manager is responsible for ensuring ***'s Quality Systems, such as Documentation, Deviation, CAPA, Change Control, Self-Inspection and Risk Management are consistently administered and followed.Key Responsibilities:1....


  • 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...


  • Novato, California, United States Randstad Full time

    Job Summary:As the world's largest staffing and recruitment agency, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Our partner is internationally known for creating cutting-edge biopharmaceuticals for patients who live with rare genetic diseases. If you're looking for an exciting...