Night-Shift Expansion MQA Specialist – GMP & EM

Piramal Pharma Limited; Lexington (KY); Vor Ort; USD 55.000 - 75.000; Vollzeit

Zusammenfassung

Piramal Pharma Solutions in Lexington seeks an Expansion MQA Specialist to perform in-process QA activities, environmental monitoring of facilities and utility systems, and QMS support per GMP/SOPs.

Reporting to the Quality Supervisor, you will work nights, review batch records, participate in audits, and maintain laboratory instruments. A BS in science and 1 year QA/EM experience are required.

Qualifikationen

• Bachelor’s degree in physical or biological sciences or related field.
• 1 year QA or environmental monitoring experience in a pharmaceutical manufacturing environment.
• Experience with IPQA/EM, cGMP or FDA regulations.
• Familiarity with cGMP, OSHA and FDA regulatory requirements.
• Proficient in MS Office applications (Word, Excel, Outlook, Access).

Aufgaben

• Understand aseptic technique and maintain clean room behaviour per cGMP.
• Perform in-process QA activities, inspections, labeling and packaging clearances per SOPs.
• Review batch records and protocols to meet disposition timelines.
• Conduct environmental monitoring of cleanrooms (viable/non-viable air/surface).
• Sample and test utilities including water, steam and compressed gases.
• Perform plate enumeration and document results.
• Assist in cleaning verification sampling and analysis.
• Participate in audits and client interactions as needed.
• Maintain laboratory instrumentation and calibrations.
• Support trend data for continuous improvement in environmental monitoring.
• Manage microbiology material inventory for EM plates.
• Prepare and summarize data for site metrics; write/revise QA/EM SOPs and reports.
• Conduct GMP investigations including root-cause analyses and risk assessments.
• Adhere to health, safety, environmental policies and PPS QMS.

Kenntnisse

Aseptic technique

cGMP compliance

Quality assurance

Verbal & written communication

Detail oriented

Technical writing

Analytical skills

Ausbildung

Bachelor's Degree in physical or biological sciences

Tools

Microsoft Office

Jobbeschreibung

Piramal Pharma Solutions in Lexington seeks an Expansion MQA Specialist to perform in-process QA activities, environmental monitoring of facilities and utility systems, and QMS support per GMP/SOPs.

Reporting to the Quality Supervisor, you will work nights, review batch records, participate in audits, and maintain laboratory instruments. A BS in science and 1 year QA/EM experience are required.