Quality Assurance Specialist

5 days ago


Winchester, Kentucky, United States Joulé Full time
Job Summary:

We are seeking a highly skilled Quality Assurance Specialist to join our team at Joulé. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our pharmaceutical products.

Key Responsibilities:

• Recommend and implement changes to Standard Operating Procedures (SOPs) and batch records as needed
• Review proposed SOP revisions and provide feedback to management
• Conduct real-time audits of batch records in 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, as well as cGMP and CFR guidance 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 in real-time
• Monitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements to identify and resolve routine errors and prevent possible deviations that affect production in real-time

Preferred Qualifications:

• Lean Six Sigma certification or other professional certifications

What We Offer:

• Competitive pay rate of $26.40/hour
• Opportunity to work on a 6-month contract-to-hire basis
• Chance to work in a regulated GMP manufacturing environment

Requirements:

• Bachelor's Degree in a related science or technical field, combined with 2 years of prior relevant work experience, or
• High School Diploma, combined with 4+ years of relevant work experience in a regulated GMP manufacturing environment

Location:

Winchester, KY 40391

Schedule:

Monday through Friday, 10pm to 6:30am

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