Quality Assurance Associate
Listed on 2026-06-27
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Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers, QA Specialist - Analyst/Manager, Data Analyst
Quality Assurance Associate
Job Title:
Quality Assurance Associate
Location:
Winchester, KY - ONSITE Duration:
Temp to Hire after 6 months Pay: $22.94/HR Shift: MON-FRI 6AM – 2:30PM + MANDATORY OVERTIME.
Position Overview:
- 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
Minimum education and experience required to perform the job:
- Bachelors degree; OR
- Associates with 1 year of related work experience; OR
- High School Diploma/GED with 2 years of related work experience
Why Kelly? Kelly® puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering & scientific talent and services since 1965. And Engineering & Scientific job seekers know Kelly® as a firm with an unmatched reputation for quality, integrity and professionalism.
Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly® to explore opportunities that suit your specific professional interests.
As a Kelly Services employee, you will have access to numerous perks, including:
- Exposure to a variety of career opportunities as a result of our expansive network of client companies
- Career guides, information and tools to help you successfully position yourself throughout every stage of your career
- Access to more than 3,000 online training courses through our Kelly Learning Center
- Weekly pay and service bonus plans
- Group-rate insurance options available immediately upon hire*
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