QA Auditor I Aveva Drug Delivery Systems
Overview
QA Auditor I at Aveva Drug Delivery Systems oversees daily support for Manufacturing Packaging R&D Technical Operations Engineering and QC ensuring GMP compliance and audit readiness. This role drives continuous improvement through proactive audits and defect resolution.
What You'll Do11
- 1Perform room and equipment line clearance and visual inspection of finished products
- 2Collect stability and retain samples from the production line
- 3Conduct Packaging Manufacturing In-process audits to verify adherence to quality standards
- 4Review batch records in real time during production
- 5Lead AQL plan preparation and execution
- 6Evaluate and impound substandard materials
- 7Sample products for online inspection and stability testing
- 8Track and trend in-process product defects
- 9Coordinate annual product inspections and reserve sampling
- 10Execute QAIP walkthroughs and maintain SOP compliance
- 11Collaborate with supervisors to resolve quality issues
Requirements11
- 15+ years building ETL pipelines with Spark and Airflow
- 23-5 seasons experience working with cGMP procedures in pharmaceutical environments
- 3High School Diploma or equivalent plus two years of college
- 4Two-four years related experience or training
- 5Excellent written and verbal English communication skills
- 6Proficiency with Microsoft Office Suite
- 7Experience with JD Edwards ERP system
- 8Ability to manage multiple priorities in a fast-paced setting
- 9Strong attention to detail
- 10Superior interpersonal skills for effective teamwork
- 11Experience with quality assurance in combination device manufacturing
Salary Insight
$52k per year
Location
Required Skills
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