QA Associate I job at System One Winchester, KY, US

Job Description

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. 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,

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