What are the responsibilities and job description for the QA Associate I position at System One Holdings, LLC?
Title : QA Associate 1
Location : Winchester KY 40391
Schedule : SUN-THURS - 10PM-6AM.
Duration : 3 month contract to hire
Education :
Bachelor's Degree in related science or technical field in combination with 2 years prior relevant work experience.
High School Diploma in combination with 4 years of relevant work experience in a regulated GMP manufacturing environment.
Requirements :
- 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 client 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.
- Monitor production manufacturing areas for compliance to SOP / cGMP / batch record and safety requirements in order to identify and resolve routine errors and prevent possible deviations that affect production real-time.
Preferred :
Lean Six Sigma, ASQ certification or other professional certifications.
