Night-Shift Senior QA Specialist, GMP & EM

Piramal Pharma Solutions Inc.; Lexington (KY); On-site; USD 90,000 - 120,000; Full time

Job summary

Piramal Pharma Solutions Inc. in Lexington, KY seeks a Senior Manufacturing QA Specialist to perform in-process QA, environmental monitoring, and CAPA-driven investigations. You will ensure cGMP compliance and support site QA activities, audits, and QMS improvements.

The role reports to QA Supervisor and requires strong documentation, regulatory knowledge, and cross-functional collaboration in a nights shift environment.

Qualifications

• Bachelor’s degree required/preferred in physical or biological sciences or related field.
• 4+ years QA or Environmental monitoring in pharmaceutical manufacturing.
• Experience with QA Plant support (IPQA/EM), cGMP or FDA guidelines.

Responsibilities

• Perform in-process QA activities and environmental monitoring.
• Lead audits and assist with QMS documentation and CAPA development.
• Review batch records, protocols, and supporting documentation for disposition.
• Provide oversight of EM activities for classified areas (air/ surfaces).
• Perform sampling and testing of site utilities (water, steam, gases).
• Lead complex GMP investigations including root-cause analysis.

Skills

QA/EM expertise

Regulatory awareness

Documentation & writing

Analytical thinking

Communication skills

Education

Bachelor’s degree in physical or biological sciences or related field

Tools

Microsoft Office

Job description

Piramal Pharma Solutions Inc. in Lexington, KY seeks a Senior Manufacturing QA Specialist to perform in-process QA, environmental monitoring, and CAPA-driven investigations. You will ensure cGMP compliance and support site QA activities, audits, and QMS improvements.

The role reports to QA Supervisor and requires strong documentation, regulatory knowledge, and cross-functional collaboration in a nights shift environment.