Quality Assurance Associate
At SRG, we create meaningful connections that empower individuals and businesses to shape tomorrow’s world.
Working as part of the SRG team, you will work with our client which are Pharmaceutical or Bio-Pharmaceutical companies to ensure work quality and accuracy for our client in the Bio Pharmaceutical Industry. The Quality Assurance Associate will be responsible for supporting the Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) audit program activities, as well as contributing to GMP/GDP Inspection activities.
Summary of Key Responsibilities
- Participate in the development of risk-based GMP/GDP auditing schedules and inspection readiness activities
- Support the GMP/GDP vendor audit, internal audit, and inspection activities
- Collaborate with internal and external customers to support GMP/GDP audit and inspection readiness activities and address audit observations
- Participate in or manage GMP/GDP internal and external audits, as well as GMP/GDP mock inspection or related activities
- Support GMP/GDP QA during regulatory inspections
- Oversee provision of GMP/GDP audit and inspection metrics for management review
- Identify and escalate critical GMP/GDP findings to Sr. Management
- Support continuous improvement activities for the GMP/GDP Audit Program
- Investigate and manage Quality Events/Investigations to determine root cause
- Implement new CAPAs, manage and track to resolution
- Participate in SOP writing/review
- Minimum BS degree in life sciences, engineering or related field
- 0-4 years experience performing internal and external audits (auditor qualification preferred).
- Previous life sciences experience a plus
- US & Global regulation knowledge a plus
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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