Quality Assurance Auditor
- Research Triangle Park, NC
Cenduit LLC is the largest IRT (interactive response technology) specialist in the world with the expertise to empower study sponsors for success by implementing a completely personalized system that puts them in control of their clinical trials. Cenduit was founded in May 2007 and emerges from a robust tradition of clinical development and supply chain expertise from two world leaders, Quintiles and Thermo Fisher Scientific.
Meeting the needs of investigator sites and patients, Cenduit offers clinical supply chain intelligence and clinical operations know-how through its IRT-driven services: rapid study start-up software, patient randomization (RTSM), patient reminders, drug supply management, and eClinical integration. Cenduit has over 500 experts worldwide in the US, UK, Switzerland, India and Japan, with clinical trial experience in more than 100 countries, interacting with more than 600,000 patients at more than 32,000 sites.
This role will support QA in developing, monitoring, and maintaining the Quality framework at Cenduit via:
- Supporting and maintaining all aspects of the Quality System in accordance with the company's quality manual, SOPs, and customer requirements.
- Taking on contributor and occasional lead roles in process definition or re-engineering for continuous improvement of operating procedures and processes.
- Providing value-added, day-to-day support, guidance, and direction to the operational teams on matters of regulatory and process compliance in service of clinical trials.
- Performing and supporting regular audits at assigned locations.
- Serve as localized escalation point for low and medium severity issues arising from assigned locations. Provide guidance and direction to key operational and delivery stakeholders in matters of compliance and best practice. Responsible to escalate high and critical severity issues to QA management.
- Assist in the development, implementation, and maintenance of Cenduit's Quality System, including facilitating process improvement activities to the product and project teams for continuous improvement.
- Supports customer audits as needed. Hosts routine sponsor audits and occasional study audits as growth opportunities. Participate/support whenever required.
- Perform and participate in internal audits to ensure that Quality Standards are being adhered to.
- Conduct ongoing training and support for new and existing staff on the Quality Manual and other key areas including Corporate SOPs, GCP, 21 CFR Part 11, validation, and process improvement/problem solving.
- Assist in the maintenance of the corrective/preventive action program, inclusive of tracking status of open actions, receiving and reviewing responses, working with departments for timely completion and periodic reports and metrics.
- Participates in the evaluation of quality events, incidents and possible complaints or compliments and the follow-up events.
- Assist, manage, and/or maintain status tracking of internal audits and responses, sponsor audits, and vendor audits.
- Support the company during external inspections as required.
- Perform Vendor Evaluation / Vendor audits as required.
- Liaise with customers and suppliers where necessary (where impacting/affected by quality issues).
- Basic familiarity with computerized systems validation methodologies.
- Basic understanding of quality management systems initiatives and standards, including experience in writing policies and procedures
- Emerging and/or basic client facing communication skills - ability to influence others to achieve objectives.
- Bachelors Degree or equivalent
- 1-5 years experience working within a regulated environment with basic familiarity with FDA and international regulations such as 21 CFR Part 11, GCP/E6, EU Directive 95/46/EC, etc.
- Experience in Quality Assurance role in a regulated environment or ISO 9000 certified company preferred
- Experience in hosting and/or conducting audits of computerized systems with clinical trial relevance.
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