DQA Specialist - E&L Lab

Role & responsibilities

1. Data Review and Validation:

• Work closely with the E&L laboratory team to ensure that data quality assurance is integrated into every stage of the analytical workflow.
• Conduct thorough reviews of analytical data generated from GC-MS, LC-MS/MS, ICP-MS, and other analytical techniques used in E&L testing.
• Validate raw data and ensure that it aligns with predefined protocols, SOPs, and regulatory standards.
• Identify any deviations or discrepancies in data and work with the scientific team to resolve them.

2. Compliance & Assurance

• Ensure that all data meets regulatory compliance requirements, including FDA, EMA, ICH, and USP guidelines.
• Prepare and maintain the E&L lab for internal and external audits by regulatory bodies and clients.
• Implement corrective and preventive actions (CAPAs) in response to audit findings or identified data issues.
• Develop and update Standard Operating Procedures (SOPs) related to data quality assurance and documentation in the E&L lab.
• Ensure the integrity and security of data throughout its lifecycle, from acquisition to reporting.

Preferred candidate profile

• 5+ years of experience in quality assurance in a laboratory setting, preferably related to E&L studies.
• Strong knowledge of regulatory guidelines (FDA, EMA, ICH, USP) and Good Laboratory Practices (GLP).
• Familiarity with data generated from analytical techniques like GC-MS, LC-MS/MS, and ICP-MS