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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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The Senior QA Specialist will collaborate closely with the internal QC laboratories and other departments within the Ultragenyx network. We nurture and reinforce an active quality culture throughout the organization and provide the framework within which that work gets done.
We will assess your level based on your experience before moving forward with full panel interviews.
This is a Flex role that will typically require onsite work 3-4 days each week, or more depending on business needs.
Responsibilities
Requirements
Senior QA Specialist
Posted: 03/17/2025
2025-03-17
2025-04-17
Employment Type:
Contract
Job Category: Quality
Job Number: 4285
Job Description
The Senior QA Specialist will collaborate closely with the internal QC laboratories and other departments within the Ultragenyx network. We nurture and reinforce an active quality culture throughout the organization and provide the framework within which that work gets done.
We will assess your level based on your experience before moving forward with full panel interviews.
This is a Flex role that will typically require onsite work 3-4 days each week, or more depending on business needs.
Responsibilities
- Provide active support for QC site operations, inclusive of associated facilities, lab operations and IT operations.
- Partner with QC and support teams relative to quality/compliance aspects of changes and systems.
- Provide review and approval of analytical method validation protocols, reports, and data packages.
- Generate and approve Certificates of Analysis (COAs) in LIMS to support batch release and regulatory filings.
- Provide Analytical QA approval of deviations and change controls.
- Support site/departmental inspection readiness programs, as needed.
- Provide quality system guidance and support for the QC laboratories, including data review processes, to ensure the health of the quality systems.
- Utilize risk management principles to continuously improve QC related processes and procedures.
Requirements
- Minimum B.S. degree in preferably microbiology, chemistry or biochemistry.
- 7 years of Quality Assurance experience in biopharmaceutical or biotechnology based GMP setting with a focus on Quality Control.
- Experience with both internal QC operations and external contract test lab operations is preferred.
- Comprehensive knowledge of FDA and EMA regulations and experience in US and international regulatory agency inspections.
- Experience leading continuous improvement efforts.
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