Overview
Senior Quality Assurance Specialist Jobs in Woburn, Massachusetts, USA at The Steely Group
Join Ultragenyx as a Senior Quality Assurance Specialist, where you will play a pivotal role in fostering a robust quality culture across our organization. This position is designed for collaborative individuals eager to work closely with our internal QC laboratories and various departments.
We assess your experience to ensure a perfect fit before proceeding to full panel interviews. This Flex role typically involves onsite work 3-4 days a week, or more depending on business needs.
Key Responsibilities:
Actively support QC site operations, covering facilities, lab, and IT operations.
Collaborate with QC and support teams on quality and compliance related to changes and systems.
Review and approve analytical method validation protocols, reports, and data packages.
Generate and approve Certificates of Analysis (COAs) in LIMS for batch release and regulatory submissions.
Provide Analytical QA approval of deviations and change controls.
Assist with site/departmental inspection readiness programs as necessary.
Guide and support quality systems for the QC laboratories, including data review processes to maintain quality health.
Employ risk management principles to drive continuous improvement in QC processes and procedures.
Qualifications:
B.S. degree in microbiology, chemistry, biochemistry, or a related field.
At least 7 years of Quality Assurance experience in a biopharmaceutical or biotechnology GMP setting, specifically focusing on Quality Control.
Preferred experience with both internal QC operations and external contract laboratory services.
Strong understanding of FDA and EMA regulations with experience in US and international regulatory agency inspections.
Proven track record of leading continuous improvement initiatives.
Title: Senior Quality Assurance Specialist
Company: The Steely Group
Location: Woburn, Massachusetts, USA
Category: Quality Assurance – QA/QC, Healthcare
