Job Overview
The Supplier Qualification Analyst II plays a key role in our Supplier Qualification Office (SQO) within our Global Regulatory Compliance & Quality Assurance (RCQA) department in supporting the qualification of third-party clinical suppliers. As a member of the SQO team, this position will be responsible for supporting the process in the qualification and requalification of third-party suppliers, who provide services/ products that directly support clinical trials
Summary Of Responsibilities
- Supports the supplier qualification process for Fortrea clinical suppliers, including the assessment of capabilities under the direction of the Sr. Manager or higher.
- Coordinates the qualification process with SMEs from Global Procurement Services (GPS), functional area SMEs, etc.
- Maintaining effective tracking of the process and completion in a timely manner.
- Includes issuance, collection, and review of supplier qualification documents i.e., RFI and ensuring proper follow-up on supplier qualification requests.
- Partner with extended QA colleagues in vendor qualification audits
- Creation/maintenance of Qualified Supplier List
- Ensure the maintenance of accurate and complete supplier files, ensuring documentation is available for QA auditors and other key stakeholders
- Participates in and supports other SQO initiatives as required
Qualifications (Minimum Required)
- Bachelor's degree from an accredited university in Life Sciences.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience (Minimum Required)
- 3+ years of experience in the life sciences industry e.g., CRO, pharma, biotech, and experience in the job discipline (vendor qualification/vendor management/QA) is preferred.
- Experience in clinical research, understanding of clinical research, and comprehensive knowledge of clinical trial services and vendors.
- 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
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