GMP Quality Assurance Specialist (Onsite)

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

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.