Senior Specialist, Quality Assurance, Clinical Quality

at Merck in Boise, Idaho, United States Job Description Job Description Our Research Laboratories Quality Assurance (QA) is an independent organization that provides quality focus at each critical stage of the product development life cycle, including post approval marketing, to ensure high-quality, safe, and effective products, contributing to the company mission of improving and saving lives around the world. Our Research Laboratories QA Clinical Quality (CQ) provide independent assurance that our company ensures the safety, rights, and well-being of participants, while complying with applicable global regulatory requirements through sound processes, procedures, and strategies for ensuring data integrity in our clinical trials.

Primary Responsibilities:

+ Leads their own specific tasks and responsibilities within a team, prioritizing time and effort towards important deliverables and producing high-quality work + Contributes to the overall goals of the team by excelling at their individual role and taking initiative to improve their own skills + Influences, partners and collaborates with other colleagues within and outside their team + Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and external relevant stakeholders (e.g. Clinical Operations), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable. + Be able to analyze and leverage critical to quality factors to identify potential risks to prepare and perform risked-based audits + Activities may include GCP audits of investigator sites, suppliers, third party collaborations and due diligence activities. + In alignment with risk assessments, supports the QAL in the identification of audit substrate for scheduling, as appropriate. + Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL and TA Head. + Interfaces and provides day-to-day support to applicable QA functional line to ensure appropriate quality oversight of assigned studies. + Assesses compliance of clinical investigator sites, vendors, study activities, clinical study reports and submission documents, and Country Offices (COs) processes against ICH (International Conference of Harmonization), applicable government agency regulations/guidelines, as well as our company policies, procedures and industry standards. The QAS should have a To view full details and how to apply, please login or create a Job Seeker account