Supplier Qualification Associate

Job description

Job Overview: The Associate plays a key role in our Supplier Qualification Office (SQO) within Global Regulatory Compliance & Quality Assurance in supporting the qualification of third-party clinical suppliers. As a member of the SQO team, this position will be responsible for supporting the quality risk assessment of third-party suppliers, who provide services/ products that directly support clinical trials. Summary of Responsibilities: • Support the supplier qualification process for Fortrea clinical suppliers, including the assessment of capabilities under the direction of the Manager-level or higher in SQO • Coordinate the quality risk assessment process with SMEs from the wider QA team, Strategic Sourcing, functional area SMEs, etc, maintaining effective tracking of the process and completion in a timely manner • Include issuance, collection and review of supplier qualification documents and ensuring proper follow up on supplier qualification requests Partner with the wider QA team in supplier qualification audits • Creation/ maintenance of Qualified Supplier List (QSL) in ensuring it provides clear information on the suppliers who have completed the quality risk assessment. • CAPA/ audit support • Participates in and supports other initiatives as required Experience (minimum required): • 1-3 years of experience in the life sciences industry e.g. CRO, pharma, biotech and experience in the job discipline (supplier qualification/ vendor management/ QA) is preferred • Experience working independently with minimal supervision and in a team environment under time and resource pressures • Excellent interpersonal, oral and written communication skills when dealing with both external and internal customers with an ability to prioritize and meet deadlines • Good presentation skills • Proficient with MS Office programs • Proactive self-starter • Multi-tasker • Creative problem solver (to improve processes, create new approaches) • Excellent Project Management skills to ensure proper proactive planning and follow up • Well Organized • Team player • Enthusiastic agent of change Qualifications (minimum required): • Bachelor level degree, preferably in a science or business discipline . Note: Fortrea may consider relevant and equivalent experience in lieu of educational requirements Work environment: • Work is performed in an office environment with exposure to electrical office equipment in their home office in their home or remotely • Occasional commute to site Physical requirement: • Frequently stationary for 6-8 hours per day. • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck • Ability to access and use a variety of computer software developed both in-house and off-the-shelf • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs • Regular and consistent attendance. • Varied hours may be required Learn more about our EEO & Accommodations request here .