Supplier Quality Specialist

Summary of Position

This role is responsible for supporting the Supplier Quality Specialist organization through the site’s Supplier Quality program meets applicable GMP regulations. This role certifies new suppliers, conducts re-assessments, authors SCAR investigations, authors vendor change controls and may conduct supplier audits.

Essential Functions

• Maintain the certified supplier list.
• Ensure the site supplier assessments are current and up to date based on quality risk.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Serve as site auditor for suppliers and ensures adherence to supplier schedule.
• Authors and owns supplier change control (notifications) process.
• Submits SCAR deviations to suppliers for defects found.
• Provide support for FDA or other regulatory agencies for on-site audits.
• Serve as site Quality SME on MSD.

Requirements

• Bachelor of Science in Biology, Chemistry or related field required.
• 3 or more years of relevant experience required.
• Experience investigating exceptions and out of specifications preferred.
• Must be able to resolve problems, handle conflict and make effective decisions under pressure Root Cause Analysis.
• Action oriented/drives for results; Ability to multitask projects.
• Must be proficient in use of Microsoft suite office products; Good computer skills, including utilizing personal computers and data entry programs.
• Good hands on, analytical, and problem solving and decision-making skills.
• Excellent writing and verbal communications skills.
• Ability to work independently and with others to accomplish goals and priorities.
• High level of energy and regular, consistent attendance.
• Verifiable working knowledge of cGMP guidelines and their application in a pharmaceutical manufacturing environment.