Overview
Quality Assurance Specialist Jobs in Winchester, KY at LanceSoft, Inc.
Title: Quality Assurance Specialist
Company: LanceSoft, Inc.
Location: Winchester, KY
Job Description:
- Recommend SOP and batch record changes as needed
- Review proposed SOP revisions and provide feedback to management
- Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters
- Perform room and equipment clearances per procedure following cleaning conducted by production.
- Perform microbial swabbing of equipment and room surfaces for environmental monitoring.
- Maintain a full understanding of all SOPs and policies along with all cGMP and CFR guidance that are applicable to the manufacturing of solid oral dosage pharmaceutical products.
Perform routine testing of in-process and finished product samples including particle size, bulk density, moisture analysis, appearance, and AQL testing real-time.
Education or Equivalent Requirements:
- Quality Assurance Associate
- Bachelor’s degree; OR Associates with 1 year of related work experience; OR High School Diploma/GED with 2 years of related work experience
