Quality Assurance Associate

Catalent; Winchester (KY); On-site; USD 52,000 - 78,000; Full time

Job summary

Catalent's Winchester, KY site seeks a Quality Assurance Associate to 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 to ensure compliance with cGMP, CFR, and Catalent SOP requirements.

Shift: F Shift (Friday - Sunday 6 PM - 6 AM; every other Monday) 100% onsite in Winchester, KY.

Qualifications

• 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.

Responsibilities

• Recommend SOP and batch record changes as needed.
• Review SOP revisions and provide feedback to management.
• Conduct real-time audits of batch records for completeness and compliance.
• Perform room and equipment clearances after production cleaning.
• Perform environmental monitoring through microbial swabbing.
• Maintain knowledge of Catalent SOPs, GMPs and CFRs.
• Perform testing of in-process and finished product samples.
• Monitor manufacturing areas for SOP and GMP compliance.
• Identify and resolve routine errors and deviations.
• Collaborate cross-functionally to assess deviations and investigations.
• Initiate deviation reports in TrackWise with documentation.
• Manage quality status of WIP and finished goods in inventory systems.
• Support investigations with data gathering and root cause analysis.
• Enforce Good Manufacturing Practice compliance.
• Provide training and coaching to personnel.
• Support process improvements and CAPA implementations.
• Investigate customer complaints.

Skills

Quality Assurance

Documentation

English proficiency

Communication

Attention to detail

Problem solving

Education

Bachelor's degree

Associate degree +1 yr related experience

High School Diploma/GED +2 yrs related experience

Tools

TrackWise

JD Edwards

Laboratory instruments

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.

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: F Shift (Friday - Sunday 6 PM - 6 AM; 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.

Notice to Agency and Search Firm Representatives

Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [e-mail] for us to investigate with local authorities.

Volunteer Work Disclosure

Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

Massachusetts Lie Detector Test Notice

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.

California Job Seekers can find our California Job Applicant Notice HERE.