Senior Quality Associate

4 weeks ago


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

Job Title: Senior Quality Associate

Job 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 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 writing, reviewing, and approving documents in Quality Management Systems in accordance with BioSpace, Inc. policies
  • Perform area walkthroughs
  • Perform other duties and projects as assigned by management

Requirements:

  • BS/BA in a scientific discipline or related field and 6-8 years of experience in a biologics manufacturing environment
  • Prior batch record review experience is required
  • 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 MSAT experience preferred

Shift Details:

Alternate Wed, Thurs-Sat 1800-0700

Benefits:

We offer shift differential pay for off-hour shifts, including swing and grave shifts. No international traveling required.

Equal Opportunity Employer:

BioSpace, Inc. is an equal opportunity employer and welcomes applications from diverse candidates. 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.



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