Supplier Qualification Associate
PharmaCROBiotechClinical ResearchRegulatory AffairsQuality Assurancecroinform
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 .
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