Supplier Qualification Associate

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

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