Quality Assurance Specialist

5 days ago


Novato, California, United States Randstad Full time
Quality Assurance (QA) Frontline Associate

Join 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 support to manufacturing operations. You will review executed batch records and associated documents to ensure compliance with approved procedures and cGMP expectations. Additionally, you will respond to quality-related incidents or non-conformances on the floor and secure necessary documentation for real-time investigations.

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 Novato Technical Services (NTS) personnel
  • Provide QA support, including authoring, review, and approval of documents in Quality Management Systems in accordance with company policies
  • Perform area walkthroughs
  • Perform other duties and projects as assigned by management

Qualifications:

  • Bachelor's degree (BS/BA) in a Scientific discipline or related field
  • Three (3) to five (5) years' experience in a biologics manufacturing environment
  • Prior batch record execution or review experience
  • Prior experience in investigation, change control, and 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

Additional Skills:

  • Batch Record Review
  • Root Cause Analysis
  • cGMP
  • Technical Services
  • Change Control
  • QMS
  • Documentation
  • Manufacturing Operations

Equal Opportunity Employer:

Randstad is an equal opportunity employer and welcomes people of all abilities. If you require a reasonable accommodation to make your application or interview experience a great one, please contact us.

Benefits:

Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).



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