Night-Shift QA Specialist, Environmental Monitoring

Piramal Pharma Limited; Lexington (KY); Vor Ort; USD 65.000 - 90.000; Vollzeit

Zusammenfassung

Piramal Pharma Solutions in Lexington, KY is seeking an EXPANSION MQA Specialist to support in-process QA, environmental monitoring, and GMP compliance. Reporting to the Quality Supervisor, you will perform QA activities, review batch records, and participate in audits.

The ideal candidate holds a Bachelor’s degree in physical or biological sciences, at least 1 year QA or EM experience in pharma, and proficiency with MS Office; strong communication, attention to detail, and technical writing

Qualifikationen

• Bachelor's degree in physical or biological sciences or related field.
• 1 year of QA or Environmental monitoring experience in pharma.
• Experience in QA Plant support (IPQA/EM) with cGMP or FDA.
• Proficiency with Microsoft Office applications.
• Strong communication skills, both written and verbal.
• Ability to read and follow written instructions.
• Detail oriented; sterile manufacturing knowledge preferred.
• Technical writing skills preferred.

Aufgaben

• Acquire understanding of aseptic technique and maintain clean room discipline under cGMP.
• Perform In-process QA activities, inspection, labeling and packaging clearances per SOPs.
• Review batch records and protocols, meet disposition timelines.
• Environmental monitoring of cleanroom areas (air and surfaces).
• Sampling and testing of utilities (water, steam, compressed gases).
• Plate enumeration and documentation of results.
• Assist in cleaning verification sample collection and analysis.
• Participate in audits and client interactions as needed.
• Maintain laboratory instrumentation and calibrations.
• Maintain EM trend data for continuous improvements.
• Inventory control for EM media plates; site metrics data preparation.
• Prepare and summarize QA/EM SOPs and technical reports.
• Conduct GMP investigations: root cause analyses, risk assessments, impact evaluations.
• Adhere to regulations and support quality management.

Kenntnisse

QA experience

Environmental monitoring

Regulatory compliance

Technical writing

MS Office

Communication skills

Attention to detail

Ausbildung

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

Tools

Microsoft Office

Jobbeschreibung

Piramal Pharma Solutions in Lexington, KY is seeking an EXPANSION MQA Specialist to support in-process QA, environmental monitoring, and GMP compliance. Reporting to the Quality Supervisor, you will perform QA activities, review batch records, and participate in audits.

The ideal candidate holds a Bachelor’s degree in physical or biological sciences, at least 1 year QA or EM experience in pharma, and proficiency with MS Office; strong communication, attention to detail, and technical writing