Manufacturing - Quality Assurance Associate

Quality Assurance Specialist in Winchester, KY

Are you passionate about ensuring quality in manufacturing processes? We are seeking a dedicated Quality Assurance Specialist to join our team in Winchester, KY. This is an excellent opportunity to work in a dynamic environment and contribute to the production of high-quality pharmaceutical products. This position offers a potential for transition from temporary to permanent employment after six months.

• Recommend and review SOP and batch record changes.
• Conduct real-time audits of batch records for accuracy and compliance.
• Perform room and equipment clearances and microbial swabbing for environmental monitoring.
• Conduct routine testing of in-process and finished product samples.
• Monitor production areas for compliance with SOP, cGMP, and safety requirements.
• Initiate and manage deviation problem reports in Trackwise.
• Manage quality status of materials in inventory systems.
• Support investigations for deviations and customer complaints.
• Provide training and coaching to manufacturing staff.
• Support site process improvements and enforce GMP compliance.

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

• Experience in pharmaceutical manufacturing or similar industry.
• Familiarity with JD Edwards inventory system and Trackwise software.
• Strong understanding of cGMP and CFR guidelines.

Join us in Winchester, KY, and be part of a team that values quality and innovation. Apply now to start your career in quality assurance!