Night Shift Expansion QA Specialist – Environmental Monitoring

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

Zusammenfassung

Piramal Pharma Solutions in Lexington is seeking an EXPANSION MQA Specialist to perform in-process QA activities, environmental monitoring, audits, and QMS support in accordance with GMP and site SOPs.

The role reports to the Quality Supervisor and involves working night shifts with a focus on maintaining compliance, reviewing batch records, and contributing to continuous improvement of QA systems.

Qualifikationen

• Bachelor's degree in physical or biological sciences or related field.
• 1 year of QA or environmental monitoring experience in pharmaceutical manufacturing.
• Ability to understand regulatory requirements (cGMP, OSHA, FDA).
• Proficiency in MS Office applications.
• Effective written and verbal communication.

Aufgaben

• Perform In-process QA activities, environmental monitoring of facilities and utilities according to GMP and SOPs.
• Conduct audits and support QMS activities.
• Review batch records and protocols to meet disposition timelines.
• Perform environmental monitoring of cleanroom areas (air/ surfaces).
• Sample and test utilities (water, steam, compressed gases).
• Assist in cleaning verification sample collection and analysis.
• Participate in audits and client interactions as needed.
• Maintain laboratory instrumentation and calibration records.
• Document and summarize data for site metrics and QA/EM reports.
• Conduct GMP investigations including root cause analyses and risk assessments.

Kenntnisse

Detail oriented

Verbal and written communication

MS Office

Ausbildung

Bachelor's degree in physical or biological sciences

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Microsoft Access

Jobbeschreibung

Piramal Pharma Solutions in Lexington is seeking an EXPANSION MQA Specialist to perform in-process QA activities, environmental monitoring, audits, and QMS support in accordance with GMP and site SOPs.

The role reports to the Quality Supervisor and involves working night shifts with a focus on maintaining compliance, reviewing batch records, and contributing to continuous improvement of QA systems.