Quality Specialist II
$96,000–$118,000 year
On-siteIrvine, California, United States
Job Summary
Oversee the Quality System by reviewing SOPs, protocols, reports, and manufacturing records to ensure compliance with FDA, ICH, and internal standards. Perform timely reviews of data and documentation supporting batch release, while validating equipment, software qualification, and calibration activities. Support and approve investigations by reviewing reports and collaborating with Corporate Quality to implement standardized processes. Ensure data integrity and accuracy across all manufacturing, testing, and distribution functions. This role drives adherence to industry regulations and continuous improvement within B. Braun's infusion therapy and pain management portfolio.
Required Qualifications
- Bachelor's degree or equivalent combination of education and experience
- A minimum of 6 years of experience in a regulated industry
- Strong knowledge of quality systems, regulatory requirements, and data integrity principles
- Excellent problem-solving, organizational, and communication skills
- Ability to work independently with general supervision and manage multiple priorities
Desired Qualifications
- Relevant industry certification
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