Clinical Quality Assurance Auditor
Quality Assurance Auditor - Morrisville, NC Office-based Who We Are Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of ”Bringing Clinical Trials to Life,” we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare. Position Overview This role is a key position within Synteract’s Quality Assurance Group. The person appointed will report to Senior QA Manager and will be responsible for preparing, conducting and reporting internal and vendor audits. This is an opportunity to be part of a restructured and re-focused QA Group with an emphasis on adding value to the Company. The role will be office based in Synteract’s office in Morrisville, NC. Specific tasks would include:
- Schedule, prepare, conducts and reports assigned audits of the Company’s projects and operational processes in accordance with approved procedures, schedules and formats. Provide clear, accurate and concise advice on GCP and compliance related questions from Operational teams.
- Must have in-depth knowledge of ICH GCP and FDA and EMA regulations and guidance.
- Write and issue audit reports in accordance with standard Company formats and timelines, ensuring clear communication of audit findings to the relevant project team members and/or functional area management.
- Review responses to audit findings for appropriateness and completeness. Follow up as appropriate to obtain audit response.
- Maintain accurate and timely documentation of QA auditing activities.
- Serve as Lead Auditor for project audits as required.
- Coordinate and conduct internal audits (project, process) and external (Investigator Site site/vendor audits);
- Provide consultancy on quality and regulated issues for QA functions and Operational teams
- Host and/or co-host sponsor audits and assist in Regulator Inspections if required;
- Create, maintain and revise departmental standard operating procedures, forms and templates;
- Work with clients/sponsors when required;
- Serve as a trainer and mentor to less experienced QA Auditors.
- Manage assigned quality issues in accordance with Company requirements;
- May be required to host Sponsor audits and assist in Regulatory Inspections
- Bachelor's degree in life sciences;
- 3-5 years of experience in a QA department in a related industry;
- Experience in conducting GCP , compliance and process audits;
- Experience in conducting all audit areas, Investigator Sites, Vendors, Data Management, Biostatistics, Safety Management, Trial Master File etc.
- Experience hosting/auditing Regulatory Authority inspections and Sponsor audits and interacting with sponsor/client representatives;
- Independent thinking and planning ability;
- Knowledge and application of GCP is required;
- Ability to travel up to 30%-40% of time;
- Excellent written and verbal communication skills;
- Exceptional teamwork skills; and
- Ability to work independently.