Quality Assurance Associate/Quality Assurance Technician

Job Description: 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 Catalent 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. * Works cross functionally to assess impact for potential deviations and assist in identifying if an investigation is required. * Initiate deviation problem reports in Trackwise for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the responsible department can be conducted. * Manage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards) * Other assignments as needed within the scope of QA Associate training curriculum. * Assist in investigations for deviations by supporting data gathering and root cause analysis * Enforcement of GMP Compliance. * Promotes teamwork and good communication. * Provide training and coaching to manufacturing staff as needed * Support site process improvements (training, efficiency projects, implementation of CAPAs) * Completes investigations of customer complaints Education or

Equivalent Requirements: Minimum education and experience required to perform the job: Quality Assurance Associate * Bachelors degree; OR * Associates with 1 year of related work experience; OR * High School Diploma/GED with 2 years of related work experience

$22 - $26 an hour - Contract