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We are seeking a highly skilled and experienced Senior Quality Assurance Specialist to join our team at Syneos Health. As a key member of our quality assurance team, you will be responsible for conducting GxP audits and other services such as CAPA management and consulting activities.
Key Responsibilities- Schedule, Conduct, and Document Audits: You will be responsible for scheduling, conducting, and documenting assigned audits of projects in accordance with approved procedures, schedules, and formats.
- Lead For-Cause Audits: You will lead for-cause audits to address suspected critical audit findings, fraud, or misconduct related to investigator sites, vendors, etc.
- Expertise in Deviation and CAPA Management: You will have expertise in management of deviations and Non-Conformities (NCs); RCA and CAPA process based on FDA, EMA, MHRA requirements specifically focused on GCP.
- Work in a Defined Process: You will work in a defined, robust, and documented end-to-end deviation and CAPA management process.
- Investigation and Communication: You will be able to determine if the investigation is commensurate with the significance and risk and determine if appropriate actions have been taken and were effective.
- Documentation and Training: You will maintain accurate and timely documentation of QA auditing activities and serve as a trainer and mentor to newly hired QA Auditors.
- Subject Matter Expertise: You will maintain subject matter expertise through training, review, and/or preparation and presentation of papers, review of guidelines, and regulations, etc.
- Demonstrated Initiative and Integrity: You will have demonstrated initiative, uncompromised integrity, and a results-oriented mindset.
- Education and Experience: You will have a Bachelor's Degree in the science/health care field or equivalent combined education and experience.
- Clinical Quality Assurance Experience: You will have extensive experience in clinical quality assurance auditing (GCP) and conduct of vendor audits (e.g. of central laboratories, clinical suppliers, IRBs, etc.).
- Regulatory Knowledge: You will have strong knowledge of all applicable Good Clinical Practice (GCP) regulations and guidelines.
- Additional Requirements: You will have good pharmacovigilance practices (GVP) clinical safety and post-marketing auditing experience, preferred. Knowledge of medical terminology is also preferred.
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.
