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Quality Assurance Associate

Hire Talent

Winchester, KY
Job Title: Quality Assurance Associate
Job Duration:6 Months On W2 (Temp to Hire)
Job Location: Winchester, KY
Shift Time: Fri, Sat, Sun 6pm - 6am + 1 day every other week + mandatory overtime.

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 *** 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 Track wise 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

Job Requirement:
  • Bachelors degree; OR
  • Associates with 1 year of related work experience; OR
  • High School Diploma/GED with 2 years of related work experience
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Vacancy posted 10 hours ago
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