Quality Assurance Associate

1 week ago


Thousand Oaks, California, United States BioSpace, Inc. Full time
About the Role

We are seeking a highly skilled Quality Assurance Associate to join our team at BioSpace, Inc. as a Sr Associate Quality Assurance. This is a critical role that requires a strong understanding of quality systems and a passion for ensuring the highest standards of quality in our products.

Key Responsibilities
  • Provide quality oversight of the manufacturing facility, including manufacturing operations, testing, inspection, and utilities.
  • Partner with colleagues in Manufacturing, Supply Chain, Facilities, and Engineering to maintain a strong culture of quality and safety.
  • Perform electronic batch record reviews and provide Maximo support and work order approval.
  • Participate in and provide quality oversight for quality records, including deviations and change controls.
  • Provide quality expertise and guidance to operational staff and cross-functional teams.
  • Review and approve controlled documents, including Standard Operating Procedures, Protocols, and Reports.
  • Ensure operations align with applicable regulations and company requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
  • Contribute to and drive continuous improvement projects in cross-functional collaboration.
  • Participate in Amgen internal/external audits and inspections.
Requirements
  • High school/GED + 4 years Quality experience OR
  • Associates + 2 years Quality experience OR
  • Bachelors + 6 months Quality experience OR
  • Master's
Preferred Qualifications
  • Bachelors Degree in Biochemistry, Biology, Chemistry, or related science field
  • Demonstrated ability to perform GMP operations, including following detailed SOPs, maintaining training, and good documentation practices
  • Experience managing projects through to completion, meeting timelines
  • Ability to evaluate documentation and operations according to company procedures
  • Experience working with Quality Systems
  • Strong organizational skills and ability to manage multiple tasks at one time
  • Effective communication skills (both written and verbal)
  • Demonstrated ability to work as both a team player and independently
  • Display leadership attributes and drive improvement initiatives
  • Solid understanding and application of aseptic behaviors and principles
About Us

BioSpace, Inc. is a leading biotechnology company dedicated to serving patients worldwide. We are committed to developing innovative treatments that take care of others, while also caring for our teammates' professional and personal growth and well-being.

We offer a comprehensive Total Rewards Plan, including health and welfare plans, financial plans, work/life balance, and career development opportunities. Our expected annual salary range for this role in the U.S. is competitive and will vary based on several factors, including relevant skills, experience, and qualifications.



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