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Quality Assurance Associate
Job Location:
Job Location:
Winchester, KY - USA
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
21 October 2026 (Yesterday)
Posted:
Application Deadline:
18 January 2027
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Job Title: Quality Assurance Associate
Job Duration:6 Months On W2 (Temp to Hire)
Job Location: Winchester KY
Job Description:
Job Requirement:
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
Required Experience:
IC
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