Quality Assurance Associate
HireTalentWinchester, KY
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Overview
Remote
On-site
Job Description
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 allSOPs 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
- 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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FAQs About Quality Assurance Associate Jobs at HireTalent
What is the work location for this position at HireTalent?
This job at HireTalent is located in Winchester, KY, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at HireTalent?
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