A career at Quintiles Transnational Corp. puts you at the corporate center of the leading worldwide pharmaceutical services organization. If you want to work for a global, fast-paced organization dedicated to improving the development and marketing of medicines, Quintiles is the place for you. Apply now for our Quality Assurance Auditor position. Purpose: Maintains the quality system continuous improvement program through the implementation and maintenance of quality standards and regulatory requirements. Responsibilities: Develops, implements and maintains the division quality principles, systems and controls through the review of departmental documentation including training manuals and standard operating procedures (SOPs) and provides expert commentary on the completeness and adequacy of support for applicable regulatory requirements specific to system compliance under federal guidelines. Maintains the internal audit program which shall include establishing and maintaining audit standards per regulatory and company requirements. Coordinates and hosts customer (client, regulatory, etc.) audits as required. Ensures all inspection and review findings are followed up to completion. Apprises senior staff of audit findings as necessary and initiates discussion with appropriate personnel to resolve issues. Assembles and maintains department quality reports for management review (Field Event Reports, Internal Incident Reports, Audit Reports, etc.), to include track and trend data analysis. Provides analysis of processes to other operational units on a periodic basis. Creates, revises, reviews and approves SOPs for department and other areas as applicable. Reviews and approves validation protocols. Understands and interprets regulatory requirements and guidelines to ensure company compliance, and to maintain certification with regulatory authorities. Participates and / or facilitates continuous quality improvement initiatives / teams. Assist in training new analysts and staff in quality system requirements and applicable regulations.
Bachelor's degree with a minimum of 3 years experience in a quality assurance, specifically in clinical research or computer systems validation position.
A strong working knowledge of GxP regulations, guidelines, and industry standards as they apply to computer systems used within the Life Sciences and Pharma industry.
A solid foundation of knowledge in Quality Assurance and Quality Management principles.
An understanding of computer system validation practices as they apply to the Life Sciences and Pharma industry.
An understanding of the Pharmaceutical Research and Development Process.
Effective organizational and analytical skills.
Ability to work independently and in a team environment.
Intermediate computer skills.
Basic mathematical / statistical skills.
Quintiles Transnational - 19 months ago
Quintiles Transnational has plenty to CRO about. One of the world's top contract research organizations (CROs), it...