Job Description

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.

Job Tags

Contract work, Work experience placement, Monday to Friday,

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