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Medvacon3 days ago

Manufacturing - Quality Assurance Associate

On-site · Winchester, Kentucky, United States

Type
Full Time
Level
Mid Level
Education
Bachelors Degree
Company size
Unknown
Industry
Healthcare Tech

Job Summary

QA Associate in a manufacturing environment responsible for maintaining and auditing SOPs and batch records, performing real-time sampling and in-process/finished product testing, environmental monitoring and microbial swabbing, ensuring compliance with cGMP and CFR guidelines, and supporting investigations, CAPAs, training, and cross-functional process improvements. Responsibilities include reviewing SOP revisions, auditing batch records, performing particle size, bulk density, moisture analysis, and AQL testing, monitoring production areas for SOP/cGMP compliance, initiating deviation reports in Trackwise, managing WIP and finished goods inventory in JD Edwards, and assisting with customer-complaint investigations and site-process improvements. Required qualifications include a Bachelor’s degree (or relevant associate/HS-equivalent experience), onsite shift duties (2PM–10:30PM with mandatory overtime), and strong emphasis on documentation, training, and GMP compliance.

Required Qualifications

  • Bachelor's degree; OR Associates with 1 year of related work experience; OR High School Diploma/GED with 2 years of related work experience
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Medvacon

Manufacturing - Quality Assurance Associate

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