QA Auditor I
$52,000–$52,000 year
On-siteMiramar, Florida, United States
Job Summary
Conduct daily room and equipment line clearances, perform visual inspections of finished products, and collect stability and retain samples from the production line. Execute in-process audits of manufacturing and packaging areas while reviewing batch records in real time to ensure compliance with cGMP regulations and Aveva's Standard Operating Procedures. Prepare AQL plans, approve shipper and clinical labels, and manage the impoundment of substandard materials. Perform surface swab sampling, monitor product defect tracking and trending, and support Annual Product Inspections. Collaborate with production supervisors to resolve quality issues and initiate investigations as required. Operates in a fast-paced environment ensuring the facility remains audit-ready at all times.
Required Qualifications
- High School Diploma or equivalent
- two-years of college
- two-four years related experience
- related training
- equivalent combination of education and experience
- Excellent written and verbal English communication skills
- Experience with Microsoft Computer Products (Words, excel, Access, PowerPoint)
- Superior interpersonal skills
- ability to work effectively in a team environment
- Ability to manage multiple priorities in a fast-paced environment
- Attention to detail
- Experience Working with cGMP procedures
- Pharmaceutical manufacturing facility experience
- Combination Device manufacturing facility experience
Desired Qualifications
- Experience in JD Edwards ERP system
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