Job Description

Job Description Quality Assurance Associate:

• 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 Company’s 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 manufacturin...