QA Associate, Real-Time GMP Compliance (Onsite)

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

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.