Quality Assurance Associate

Job Title:

Quality Assurance Associate

Location:

Winchester, KY (ONSITE)

Duration:
Temp to Hire after 6 months

Pay: $26.38/hr

Shift: FRI, SAT, SUN 6PM - 6AM + 1 DAY EVERY OTHER WEEK + MANDATORY OVERTIME

• 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 to identify and resolve routine errors and prevent possible deviations that affect production real‑time
• Work 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 goods materials on physical inventory and in inventory system (JD Edwards)
• Assist in investigations for deviations by supporting data gathering and root cause analysis
• Enforce GMP compliance
• Promote teamwork and good communication
• Provide training and coaching to manufacturing staff as needed
• Support site process improvements (training, efficiency projects, implementation of CAPAs)
• Complete investigations of customer complaints

• Bachelor's degree; OR
• Associate's degree with 1 year of related work experience; OR
• High School Diploma/GED with 2 years of related work experience

As a Kelly employee, you will have access to numerous perks, including:

• Exposure to a variety of career opportunities through 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
• Voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short‑term disability
• Retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year)
• Transit spending account
• Paid sick leave under the applicable state or local plan

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce.

Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E‑Verify and will provide the federal government with your Form I‑9 information to confirm that you are authorized to work in the U.S.