Quality Assurance Specialist Jobs in Kentucky
Quality Assurance Specialist jobs in Kentucky are concentrated in Louisville, Lexington, and Bowling Green, where manufacturing, automotive, and food production drive consistent demand for inspection, compliance, and process improvement specialists at every level from entry-level technician to senior QA manager. Major employers with established Kentucky operations include Toyota, Humana, and Brown-Forman, all of which maintain active quality functions tied to production, healthcare administration, and spirits manufacturing. The most in-demand specialties are ISO compliance, supplier quality, and pharmaceutical or medical device quality systems. See the openings below and apply to the ones that match your experience.
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Showing 5 of 24+ Quality Assurance Specialist jobs
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 Supervisor, Quality Assurance to join our team at the Winchester, KY site. This role provides leadership and supervision within the Quality Assurance function, ensuring compliance with Quality Systems, Finished Product Batch Release, and Change Control. The position supports regulatory inspections, customer audits, and continuous improvement initiatives. It’s a great opportunity to contribute to a high‑performing team dedicated to maintaining the highest standards of quality and compliance.
Shift: Monday-Friday, 2 PM - 10:30 PM
Location: Winchester, KY
100% Onsite
The Role
- Ensure Quality systems comply with corporate and site procedures as well as industry standards, including Annual Product Reviews, Complaints, Investigations, Corrective and Preventive Actions, and Training.
- Supervise the Quality Assurance Associates.
- Participate in Regulatory (FDA) Inspections and Customer Audits.
- Author and maintain detailed Standard Operating Procedures defining Winchester’s Quality Systems.
- Facilitate Investigations, root cause analysis, Complaints process, and Annual Product Review process.
- Manage and track documentation of Corrective and Preventive Action commitments and related trending processes.
- Recommend process changes based on trends from CAPA, Complaints, and Annual Product Reviews.
- Serve as the Quality department liaison and subject matter expert to other departments, customers, and regulatory representatives.
- Act as subject matter expert in TrackWise, Documentum, and other Quality software platforms.
- Communicate and implement Human Resources policies within the department.
- Maintain documentation related to employee performance and timekeeping, and administer discipline as appropriate in coordination with Human Resources.
- Ensure adherence to quality standards governed by current Good Manufacturing Practices, company Quality Policies, and site Standard Operating Procedures.
- Propose, implement, and enforce quality improvements.
- Perform other duties as required.
The Candidate
Minimum Requirements
- Bachelor's Degree with 2+ years of related work experience; OR Associate Degree with 3+ years of related work experience; OR High School Diploma/GED with 4+ years of related work experience.
- Batch review and cGMP experience totaling 2+ years.
- Strong analytical and investigative skills.
- Proficient in English verbal and written communication skills to convey and receive ideas and instructions within and outside the organization.
- Proficiency in Microsoft Word, PowerPoint, Excel, and Access.
- Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent‑sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.
- Physical Requirements: Individual may be required to sit for an extended period of time. Specific vision requirements include reading of written documents and frequent use of computer monitor. Sustained sitting at desk or workstation with use of phones, computers, and other office equipment required for the position. Static stance/standing as required. File/folder storage with non‑repetitive light weight lifting, reaching, and forward bending as necessary. Infrequent overhead lifting less than or equal to 15 lbs with the ability to lift up to 35 lbs and push/pull 40 lbs.
Preferred Skills & Background
- Prior supervisory or management experience (will immediately have 5 reports).
- TrackWise Quality Management System experience.
- Strong technical writing skills for investigations, deviations, Corrective and Preventive Actions, and root cause analysis.
- Bachelor’s degree in Life Science.
Why You Should Join Catalent
- Positive and fast‑paced working environment focusing on continual improvement and innovation.
- Competitive Paid Time Off plus 8 paid holidays.
- Medical, dental, and vision benefits effective day one of employment.
- Tuition Reimbursement – support to complete or earn a new degree.
- 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 initiatives, including Adopt‑a‑Highway Clean‑up participation.
- Defined career path with annual performance reviews and growth potential within an organization dedicated to improving lives.
- WellHub program promoting physical and mental wellness.
- Perkspot offering exclusive discounts from over 900 merchants across various 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 DisabilityAccommodations@catalent.com. 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 spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
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.
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 Supervisor, Quality Assurance to join our team at the Winchester, KY site. This role provides leadership and supervision within the Quality Assurance function, ensuring compliance with Quality Systems, Finished Product Batch Release, and Change Control. The position supports regulatory inspections, customer audits, and continuous improvement initiatives. It’s a great opportunity to contribute to a high‑performing team dedicated to maintaining the highest standards of quality and compliance.
Shift: Monday-Friday, 2 PM - 10:30 PM
Location: Winchester, KY
100% Onsite
The Role
- Ensure Quality systems comply with corporate and site procedures as well as industry standards, including Annual Product Reviews, Complaints, Investigations, Corrective and Preventive Actions, and Training.
- Supervise the Quality Assurance Associates.
- Participate in Regulatory (FDA) Inspections and Customer Audits.
- Author and maintain detailed Standard Operating Procedures defining Winchester’s Quality Systems.
- Facilitate Investigations, root cause analysis, Complaints process, and Annual Product Review process.
- Manage and track documentation of Corrective and Preventive Action commitments and related trending processes.
- Recommend process changes based on trends from CAPA, Complaints, and Annual Product Reviews.
- Serve as the Quality department liaison and subject matter expert to other departments, customers, and regulatory representatives.
- Act as subject matter expert in TrackWise, Documentum, and other Quality software platforms.
- Communicate and implement Human Resources policies within the department.
- Maintain documentation related to employee performance and timekeeping, and administer discipline as appropriate in coordination with Human Resources.
- Ensure adherence to quality standards governed by current Good Manufacturing Practices, company Quality Policies, and site Standard Operating Procedures.
- Propose, implement, and enforce quality improvements.
- Perform other duties as required.
The Candidate
Minimum Requirements
- Bachelor's Degree with 2+ years of related work experience; OR Associate Degree with 3+ years of related work experience; OR High School Diploma/GED with 4+ years of related work experience.
- Batch review and cGMP experience totaling 2+ years.
- Strong analytical and investigative skills.
- Proficient in English verbal and written communication skills to convey and receive ideas and instructions within and outside the organization.
- Proficiency in Microsoft Word, PowerPoint, Excel, and Access.
- Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent‑sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.
- Physical Requirements: Individual may be required to sit for an extended period of time. Specific vision requirements include reading of written documents and frequent use of computer monitor. Sustained sitting at desk or workstation with use of phones, computers, and other office equipment required for the position. Static stance/standing as required. File/folder storage with non‑repetitive light weight lifting, reaching, and forward bending as necessary. Infrequent overhead lifting less than or equal to 15 lbs with the ability to lift up to 35 lbs and push/pull 40 lbs.
Preferred Skills & Background
- Prior supervisory or management experience (will immediately have 5 reports).
- TrackWise Quality Management System experience.
- Strong technical writing skills for investigations, deviations, Corrective and Preventive Actions, and root cause analysis.
- Bachelor’s degree in Life Science.
Why You Should Join Catalent
- Positive and fast‑paced working environment focusing on continual improvement and innovation.
- Competitive Paid Time Off plus 8 paid holidays.
- Medical, dental, and vision benefits effective day one of employment.
- Tuition Reimbursement – support to complete or earn a new degree.
- 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 initiatives, including Adopt‑a‑Highway Clean‑up participation.
- Defined career path with annual performance reviews and growth potential within an organization dedicated to improving lives.
- WellHub program promoting physical and mental wellness.
- Perkspot offering exclusive discounts from over 900 merchants across various 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 DisabilityAccommodations@catalent.com. 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 spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
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.
See All 24 Quality Assurance Specialist Jobs in Kentucky
Find roles in Kentucky that match your experience and apply in just a few clicks.
Find JobsQuality Assurance Specialist Jobs by City in Kentucky
Where Kentucky roles are concentrated, by current openings.
Quality Assurance Specialist Job Market in Kentucky
A snapshot from current Kentucky openings, updated as new roles post.
Who's Hiring
Top Industries Hiring
- Construction & Real Estate
What Kentucky Employers Look For
The qualifications that appear most often in quality assurance specialist jobs across Kentucky.
- Bachelor's degree in a technical, scientific, or engineering field required
- Hands-on experience with ISO 9001 or similar quality management systems
- Proficiency with inspection tools, measurement equipment, and quality documentation
- Familiarity with CAPA processes, root cause analysis, and corrective action reporting
- Experience working in manufacturing, automotive, food production, or healthcare environments
- Strong written communication skills for producing audit reports and quality records
Quality Assurance Specialist Jobs in Kentucky: Frequently Asked Questions
How do you become a quality assurance specialist in Kentucky?
Most Kentucky employers require a bachelor's degree in engineering, biology, chemistry, or a related technical field, though associates degree holders with relevant manufacturing or lab experience are regularly hired into entry-level QA roles. Kentucky does not require a state-issued license for most quality assurance positions, but industry certifications such as Certified Quality Auditor or Certified Quality Technician from the American Society for Quality are widely recognized and often preferred by Kentucky manufacturers and healthcare employers.
Which companies hire quality assurance specialists in Kentucky?
Employers hiring quality assurance specialists in Kentucky right now include IPG, Atkore, and Maximus, based on current listings on Migrate Mate as of November 2026. Kentucky's automotive, spirits, healthcare, and food manufacturing sectors generate some of the most consistent QA hiring in the region.
Which Kentucky cities have the most quality assurance specialist jobs?
Louisville, Lexington, and Kentucky lead Kentucky for quality assurance specialist openings. Louisville anchors the market with its deep concentration of healthcare, logistics, and manufacturing employers, while Lexington and Bowling Green draw consistent QA hiring from automotive suppliers and regional production facilities, including Toyota's large Georgetown plant just north of Lexington.
Are there remote quality assurance specialist jobs in Kentucky?
Yes, but they're less common than in purely analytical fields because many QA roles require on-site inspection, lab work, or floor-level auditing. About 44% of quality assurance specialist openings tied to Kentucky are remote or hybrid as of November 2026, with remote-eligible roles most often found in document control, supplier quality oversight, and quality systems administration.
How can I get hired as a quality assurance specialist in Kentucky with little or no experience?
The most realistic entry path is a quality technician or production inspector role at one of Kentucky's large manufacturers, where on-the-job exposure to ISO processes and inspection methods builds the foundation for a specialist position. Toyota's Georgetown facility and major Louisville-area medical device companies regularly hire associate-level QA technicians without prior formal QA titles, and a Certified Quality Improvement Associate credential from the American Society for Quality gives candidates without direct experience a concrete credential that Kentucky employers recognize.
Where can I find and apply to quality assurance specialist jobs in Kentucky?
You can find and apply to quality assurance specialist jobs in Kentucky on Migrate Mate, which lists current Kentucky openings updated regularly. Search for roles that fit your experience level and specialization, then apply directly to the ones that match.
See All 24 Quality Assurance Specialist Jobs in Kentucky
Find roles in Kentucky that match your experience and apply in just a few clicks.
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