Quality Assurance Associate

Catalent; Winchester (KY); On-site; USD 55,000 - 70,000; Full time

Benefits offered by this job

Competitive PTO

8 paid holidays

Benefits from day one

Tuition reimbursement

Job summary

Catalent is seeking a Quality Assurance Associate for its Winchester, KY site to provide quality support for solid oral dosage product manufacturing. Responsibilities include reviewing and approving documents, monitoring production in real time, and testing in-process and finished products for compliance with cGMP, CFR, and Catalent SOPs.

The role operates on an E shift (Fri-Sun, 6 AM–6 PM) and is 100% onsite.

Qualifications

• Bachelor's degree or equivalent; or Associate degree with 1 year related experience; or High School Diploma/GED with 2 years related experience.
• Familiarity with basic laboratory instrumentation.
• Excellent documentation and handwriting skills.
• Strong written and verbal communication. Proficiency in English.
• Knowledge of Good Laboratory Practices (GLP).
• Experience with continuous improvement techniques.
• Ability to work with limited supervision on routine tasks.

Responsibilities

• Review and approve documents and batch records.
• Monitor manufacturing activities in real time and test in-process samples.
• Ensure compliance with cGMP, CFR and Catalent SOPs; support continuous improvement initiatives.
• Perform real-time audits of batch records and environmental monitoring.
• Collaborate cross-functionally to assess deviations and determine investigation requirements.
• Initiate deviation reports with sufficient documentation in TrackWise.

Skills

Laboratory instrumentation

Safety mindset

Math & computer skills

Communication skills

Written/verbal instruction adherence

Independent work

Documentation handwriting

Technical writing

Good Laboratory Practices

Continuous improvement

Working under pressure

Education

Bachelor's/Associate/High School with related experience

Job description

About Site

Catalent’s Winchester, KY site is the company’s flagship U.S. manufacturing location for large‑scale oral solid dose forms, operating from a 180,000‑square‑foot facility with fully integrated development and analytical services. The site specializes in complex and controlled‑release oral dose technologies, supporting product development, technology transfer, and commercial manufacturing across pharmaceutical and consumer health programs. Winchester has a long commercial manufacturing track record, having launched 100+ products and producing billions of tablets and capsules annually, making it a critical site within Catalent’s oral dose network.

About Site

Catalent’s Winchester, KY site is the company’s flagship U.S. manufacturing location for large‑scale oral solid dose forms, operating from a 180,000‑square‑foot facility with fully integrated development and analytical services. The site specializes in complex and controlled‑release oral dose technologies, supporting product development, technology transfer, and commercial manufacturing across pharmaceutical and consumer health programs. Winchester has a long commercial manufacturing track record, having launched 100+ products and producing billions of tablets and capsules annually, making it a critical site within Catalent’s oral dose network.

Position Summary

We have an opportunity for a Quality Assurance Associate to join our team. In this role, you will provide quality support for the manufacturing of solid oral dosage products. You will review and approve documents, monitor manufacturing activities in real time, and test in-process and finished product samples. This position ensures compliance with cGMP, CFR, and Catalent SOP requirements while supporting continuous improvement initiatives.

Shift: E Shift (Friday - Sunday 6 AM - 6 PM; every other Monday)

Location: Winchester, KY

100% Onsite

The Role

• Recommend Standard Operating Procedure and batch record changes as needed.
• Review proposed Standard Operating Procedure revisions and provide feedback to management.
• Conduct real-time audits of batch records for completeness, documentation accuracy, calculation verification, and compliance with critical process parameters.
• Perform room and equipment clearances following production cleaning activities.
• Perform environmental monitoring through microbial swabbing of equipment and room surfaces.
• Maintain working knowledge of all applicable Catalent Standard Operating Procedures, policies, current Good Manufacturing Practices, and Code of Federal Regulations requirements.
• Perform routine testing of in-process and finished product samples, including particle size analysis, bulk density testing, moisture analysis, appearance evaluations, and Acceptable Quality Level testing.
• Monitor manufacturing areas to ensure compliance with Standard Operating Procedures, current Good Manufacturing Practices, batch records, and safety requirements.
• Identify and resolve routine errors and prevent deviations in real time.
• Collaborate cross-functionally to assess potential deviations and determine investigation requirements.
• Initiate deviation reports in TrackWise with sufficient documentation for investigation.
• Manage quality status of work-in-process and finished goods in both physical inventory and JD Edwards inventory systems.
• Support investigations by gathering data and assisting with root cause analysis.
• Enforce Good Manufacturing Practice compliance.
• Promote teamwork and effective communication.
• Provide training and coaching to manufacturing personnel as needed.
• Support site process improvements, training initiatives, efficiency projects, and Corrective and Preventive Action implementations.
• Investigate customer complaints.
• Perform other duties as assigned.

The Candidate

Minimum Requirements

• Bachelor's degree; OR Associate degree with 1 year of related experience; OR High School Diploma/GED with 2 years of related experience.
• Familiarity with basic laboratory instrumentation.
• Safe work habits.
• Basic math and computer skills.
• Strong communication skills and English proficiency.
• Ability to follow written and verbal instructions.
• Ability to work with limited supervision on routine tasks.
• Excellent documentation and handwriting skills.
• Technical writing skills.
• Knowledge of Good Laboratory Practices.
• Experience with continuous improvement techniques.
• Ability to work effectively under pressure and meet deadlines. Prolonged sitting, standing, and walking. Frequent computer use and document review.

Preferred Skills & Background

• Lean Six Sigma certification.
• American Society for Quality certification.
• Other relevant professional certifications.

Why You Should Join Catalent

• Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic.
• Competitive Paid Time Off plus 8 paid holidays.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition Reimbursement – support to finish your degree or earn a new one.
• Site-based Employee Engagement activities such as NCAA Basketball Brackets, Golf Scrambles, Annual Onsite Pet Adoption Events, and Mentorship Partnerships with Local Schools.
• Employee Resource Groups focusing on Diversity and Inclusion.
• Environmentally friendly, community engagement green initiatives including Adopt-a-Highway Clean-up.
• Defined career path and annual performance review and feedback process with potential for career growth.
• WellHub program to promote overall physical and mental wellness.
• Perkspot offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.