QA Controlled Docs Sr. Coordinator
Full-timeSeniorBachelors
Description
<p><b><span class="emphasis-2">Summary of Responsibilities:</span></b></p><ul><li>Follow applicable departmental Standard Operating Procedures and Work Instructions.</li><li>Complete required trainings according to required timelines.</li><li>Administer controlled documents ensuring availability to the end user.</li><li>Track and report metrics as determined by management according to required timelines.</li><li>Assist with implementation of new/revised processes and procedures.</li><li>Demonstrated ability to communicate effectively.</li><li>Perform checks to ensure quality of work completed.</li><li>Ensure timely escalation and resolution management of issues impacting controlled document release.</li><li>Ensure Regulatory Compliance and Quality Assurance (RC and QA) responsibilities, as indicated in applicable controlled documents, are followed.</li><li>All other duties as needed or assigned.</li></ul><p></p><p><span class="emphasis-2"><b>Qualifications (Minimum Required):</b></span></p><ul><li>A minimum of a bachelor’s degree in Life Sciences preferred (or equivalent Life Science experience).</li></ul><p></p><p><b><span class="emphasis-2">Experience (Minimum Required):</span></b></p><ul><li>4 to 6 years in regulatory environment (experience in GXP roles).</li><li>Strong knowledge of <b>QMS, CAPA management, and Veeva Vault</b>.</li><li>Experience in audit processes is an added advantage.</li><li>Strong interpersonal skills with ability to work well with others.</li><li>Demonstrated ability to plan, prioritize, organize and communicate effectively.</li><li>Demonstrated ability to pay attention to detail.</li><li>Strong analytical skills.</li><li>Ability to deliver consistent high quality of work.</li><li>Ability to use computer and departmental tools.</li></ul><p></p><p><span class="emphasis-2"><b>Preferred Qualifications Include:</b></span></p><ul><li>Fortrea may consider relevant and equivalent experience in lieu of educational requirements.</li></ul><p></p><p><span class="emphasis-2"><b>Physical Demands/Work Environment:</b></span></p><ul><li>Office-based (5 days per week), as required by the line manager.</li></ul><p></p><p><span>Learn more about our </span><a href="https://careers.fortrea.com/us/en/eeo-and-accommodations" target="_blank">EEO & Accommodations request here</a><span>.</span></p>