GMP QA Specialist — Night Shift, Cleanroom & Microbiology

Piramal Pharma Limited; Lexington (SC); On-site; USD 60,000 - 78,000; Full time

Job summary

Piramal Pharma Solutions in Lexington is seeking an Expansion MQA Specialist to perform in-process QA activities, environmental monitoring, and QMS support under GMP conditions.

You will review batch records, assist in audits, maintain calibration of lab instruments, and help drive continuous improvement through trend analysis. This night-shift role requires a Bachelor’s in physical or biological sciences and at least 1 year in QA or environmental monitoring in pharma.

Qualifications

• Bachelor's degree in physical or biological sciences or related field preferred.
• 1 year of Quality assurance or Environmental monitoring experience in a pharmaceutical manufacturing environment.
• Experience in QA Plant support (IPQA/EM), cGMP or FDA regulatory guidelines.
• Knowledge of regulatory requirements (cGMP, OSHA, FDA).
• Proficiency with MS Office (Word, Excel, Outlook, Access).
• Ability to communicate effectively in writing and verbally.
• Ability to read and follow written instructions.
• Detail oriented; sterile manufacturing understanding preferred.
• Technical writing skills preferred.

Responsibilities

• Understand aseptic technique and maintain clean room discipline per cGMPs.
• Perform all in-process QA activities, inspections, labeling and packaging line clearances per SOPs.
• Review batch records and protocols to meet timelines and disposition requirements.
• Perform environmental monitoring of cleanroom areas (air and surfaces).
• Sample and test utilities (water, steam, compressed gases).
• Conduct plate enumeration and document results.
• Assist with cleaning verification sampling and analysis.
• Participate in audits and client site interactions as needed.
• Maintain laboratory instruments and calibrations.
• Analyze environmental monitoring trends to drive improvements and identify issues.
• Support microbiology material inventory for EM media plates.
• Prepare and summarize data; write/review QA and EM SOPs and technical reports.
• Conduct GMP investigations with root-cause analyses and risk assessments.

Skills

QA experience

Environmental monitoring

GMP knowledge

Regulatory awareness

Communication skills

Detail oriented

Education

Bachelor's degree in physical or biological sciences

Tools

Microsoft Office

Job description

Piramal Pharma Solutions in Lexington is seeking an Expansion MQA Specialist to perform in-process QA activities, environmental monitoring, and QMS support under GMP conditions.

You will review batch records, assist in audits, maintain calibration of lab instruments, and help drive continuous improvement through trend analysis. This night-shift role requires a Bachelor’s in physical or biological sciences and at least 1 year in QA or environmental monitoring in pharma.