Expansion QA Specialist (GMP & EM)

Piramal Pharma Solutions Inc.; Lexington (KY); On-site; USD 65,000 - 90,000; Full time

Job summary

Piramal Pharma Solutions is seeking an EXPANSION MQA Specialist to join the Quality Assurance team in Lexington. The role focuses on in-process QA activities, environmental monitoring, audits, and QMS support per GMP and site SOPs.

The position reports to the Quality Supervisor and works night shifts, contributing to batch records review, GMP investigations, and data documentation. Strong regulatory knowledge and written communication are essential.

Qualifications

• Bachelor's degree in physical or biological sciences or related field.
• 1 year of QA or Environmental monitoring experience in pharmaceutical manufacturing.
• Experience with IPQA/EM, cGMP or FDA regulatory guidelines.
• Proficiency in Microsoft Office (Word, Excel, Outlook and Access).
• Strong written and verbal communication; detail oriented.

Responsibilities

• Acquire understanding of aseptic technique; maintain clean room discipline and cGMP compliance.
• Perform In-process QA activities, inspections, labeling and line clearances per SOPs.
• Review batch records and protocols; ensure timely batch disposition.
• Conduct environmental monitoring of cleanrooms (air and surfaces).
• Sample and test utilities including water, steam and gases.
• Document plate enumeration and testing results; assist in cleaning verification.
• Participate in audits and client interactions as needed by management.
• Maintain laboratory instrumentation and calibrations; track trend data.

Skills

Communication

Detail oriented

Technical writing

Education

Bachelor's Degree in physical or biological sciences or related field

Tools

Microsoft Office

Job description

Piramal Pharma Solutions is seeking an EXPANSION MQA Specialist to join the Quality Assurance team in Lexington. The role focuses on in-process QA activities, environmental monitoring, audits, and QMS support per GMP and site SOPs.

The position reports to the Quality Supervisor and works night shifts, contributing to batch records review, GMP investigations, and data documentation. Strong regulatory knowledge and written communication are essential.