Quality Assurance Associate (weekend nights)

About the role

Pay: $26.38/hr. The QA Associate will be responsible for ensuring compliance with SOPs, cGMP, and CFR guidance in the manufacturing of solid oral dosage pharmaceutical products.

Responsibilities

• Recommend SOP and batch record changes as needed
• Review proposed SOP revisions and provide feedback to management
• Perform 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 Catalent SOPs and policies along with all cGMP and CFR guidance
• 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
• Initiate deviation problem reports in Trackwise for issues discovered by QA
• Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards)
• Assist in investigations for deviations by supporting data gathering and root cause analysis
• Enforce GMP Compliance and promote teamwork and good communication
• Provide training and coaching to manufacturing staff as needed
• Support site process improvements (training, efficiency projects, implementation of CAPAs)
• Complete investigations of customer complaints

Requirements

• Bachelor's degree; OR Associate's with 1 year of related work experience; OR High School Diploma/GED with 2 years of related work experience