Senior Mfg QA Specialist - GMP/EM Lead (Nights)

Piramal Pharma Limited; Lexington (KY); On-site; USD 85,000 - 120,000; Full time

Job summary

Piramal Pharma Solutions in Lexington seeks a Sr. Mfg QA Specialist to perform in-process QA activities, environmental monitoring, and GMP-compliant batch support.

The role oversees EM, sterilization-related processes, and audits, reporting to the QA Supervisor. You will review batch records, support investigations, ensure regulatory compliance, and guide QA activities with strong documentation and technical writing skills.

Qualifications

• Bachelor’s degree in physical or biological sciences or related field.
• 4+ years of QA or Environmental monitoring experience in pharma manufacturing.
• Experience with QA Plant support (IPQA/EM), cGMP or FDA regulations.
• Proficiency with Microsoft Office (Word, Excel, Outlook, Access).
• Strong written and verbal communication skills.
• Ability to read and follow written instructions.
• Detail oriented.
• Understanding of sterile manufacturing preferred.
• Technical writing skills preferred.

Responsibilities

• Perform in-process QA activities, environmental monitoring, and line clearances.
• Review batch records, protocols, and supporting documentation for batch disposition.
• Lead environmental monitoring and testing of site utilities and microbiological testing.
• Support cleaning verification, calibration, and qualification activities.
• Prepare and revise SOPs, reports, risk assessments, and QA documentation.
• Provide QA oversight during client/internal/regulatory audits (FDA/MHRA).
• Assist in investigations (root-cause analysis, CAPA) and continuous improvement.
• Coordinate material disposition in SAP and support client technical discussions.

Skills

Communication skills

Attention to detail

Technical writing

Sterile manufacturing knowledge

Regulatory compliance

Education

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

Tools

Microsoft Office

Job description

Piramal Pharma Solutions in Lexington seeks a Sr. Mfg QA Specialist to perform in-process QA activities, environmental monitoring, and GMP-compliant batch support.

The role oversees EM, sterilization-related processes, and audits, reporting to the QA Supervisor. You will review batch records, support investigations, ensure regulatory compliance, and guide QA activities with strong documentation and technical writing skills.