Senior QA Specialist
Virtual Vocations Inc, New York, NY, United States
A company is looking for a Senior QA Specialist to drive compliance and quality across biometric services and computer systems.
Key Responsibilities
Conduct internal and vendor audits, review Trial Master Files, and report audit findings Maintain and develop Quality Management System documents, ensuring compliance with regulations Collaborate on computer system validation and ensure systems meet regulatory requirements
Required Qualifications
Bachelor's degree in life sciences, computer science, or a related field Minimum of 5 years of QA experience in clinical research or regulated software environments Strong knowledge of GxP, ICH-GCP, and 21 CFR Part 11 Proven experience in conducting audits and managing CAPAs Preferred experience with eClinical or biometric services and familiarity with electronic QMS platforms
Conduct internal and vendor audits, review Trial Master Files, and report audit findings Maintain and develop Quality Management System documents, ensuring compliance with regulations Collaborate on computer system validation and ensure systems meet regulatory requirements
Required Qualifications
Bachelor's degree in life sciences, computer science, or a related field Minimum of 5 years of QA experience in clinical research or regulated software environments Strong knowledge of GxP, ICH-GCP, and 21 CFR Part 11 Proven experience in conducting audits and managing CAPAs Preferred experience with eClinical or biometric services and familiarity with electronic QMS platforms