What are the responsibilities and job description for the QA Associate – Medical Device position at Intellectt Inc?
Role: QA Associate – Medical Device
Location: Winchester, KY
Duration: 6 Months on W2 (Temp to Hire)
Timings: Mon-Fri (2PM - 10:30PM) (OT on Weekends)
100% On-Site
Overview
Location: Winchester, KY
Duration: 6 Months on W2 (Temp to Hire)
Timings: Mon-Fri (2PM - 10:30PM) (OT on Weekends)
100% On-Site
Overview
- Support quality functions in manufacturing solid oral dosage products, ensuring compliance with cGMP, CFR, and SOP.
- Recommend and review SOP and batch record changes.
- Conduct real-time audits and monitoring of batch records.
- Perform equipment and room clearances post-cleaning.
- Conduct microbial swabbing for environmental monitoring.
- Routine testing of in-process and finished products.
- Monitor production areas for compliance and resolve errors.
- Initiate and assist in deviation investigations.
- Manage quality status in inventory systems.
- Enforce GMP compliance and promote teamwork.
- Provide training and support process improvements.
- Support customer complaint investigations.
- Preferred: Bachelors in related science/technical field 2 years relevant experience.
- Minimum: High School Diploma 4 years relevant experience in GMP manufacturing.
- Desired: Lean Six Sigma, ASQ certification, or other professional certifications.
