QA Associate I from Joulé
Winchester, KY 40391
About the Job
Title: QA Associate 1
Location: Winchester KY 40391
Schedule: Monday through Friday 2:00pm to 10:30pm
Duration: 6 month contract to hire
Pay Rate: $26.40/hr
Education:
Bachelor’s Degree in related science or technical field in combination with 2 years prior relevant work experience. OR
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.
Location: Winchester KY 40391
Schedule: Monday through Friday 2:00pm to 10:30pm
Duration: 6 month contract to hire
Pay Rate: $26.40/hr
Education:
Bachelor’s Degree in related science or technical field in combination with 2 years prior relevant work experience. OR
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.
Salary
26 - 26 /year
