System One Holdings, LLC
QA Associate I
System One Holdings, LLC, Winchester, Kentucky, us, 40392
Title : QA Associate 1
Location : Winchester KY 40391
Schedule : Monday through Friday 10pm to 6:30am
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 10pm to 6:30am
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.