Sr QA Supplier Specialist

Job Summary

The Sr QA Supplier Specialist is responsible for supporting the company's short and long term goals for maintaining regulatory, ISO, and global compliance. Assures supplier management and internal audit processes are executed and are in compliance to established procedures. This position has no supervisory responsibilities.

Responsibilities

• Facilitates activities associated with supplier management program and supports qualification of new and existing suppliers
• Collaborates with cross-functional groups to complete supplier (re)qualification activities
• Interfaces with suppliers for audits (on-site, virtual, hybrid, or document) and requests (re)qualification documentation
• Performs supplier (re)qualification audit
• Collects and reviews supplier (re)qualification documentation
• Prepares supplier (re)qualification reports or assessment/evaluation reports
• Updates and maintains regional (US QA Compliance) supplier tracking databases. Updates global supplier tracking databases
• Assists team members with supplier qualification activities as needed
• Supports local, regional, and global departments with their questions/requests relating to suppliers
• Manages and maintains Approved Vendor List
• Facilitates activities associated with Regional internal audit program
• Assure internal audits are scheduled, conducted, and closed
• Participates in internal audit as a Lead or Co-auditor
• Plans, prepares, and conducts internal audit
• Collaborates as Lead or Co-auditor with other auditors (Lead or Co-auditor) to draft audit report, review CAPA Plan, and issue audit closure
• Interface with auditees
• Updates and maintains internal audit tracking database
• Facilitates activities associated with Quality Agreement
• Executes or supports supplier quality agreement according to defined business relationship with suppliers
• Executes or supports inter-company quality agreement according to defined business relationship with other non-FK USA entities
• Collaborates with cross-functional groups and/or suppliers to draft, review, and/or finalize quality agreement
• Performs periodic review of executed quality agreements and execute action(s) based on the review outcome
• Updates and maintains regional (US QA Compliance) Quality Agreement database
• Updates global Quality Agreement database
• Assist with preparing monthly management review presentation
• Prepares monthly supplier data for product APQR as requested from Production Units
• Assists team members in supporting internal, external, customer, and regulatory inspection, as needed.
• Supports maintenance or process improvement of programs for supplier management, internal audit, and quality agreement, as needed.

Requirements

• Must have a Bachelor's degree in the sciences with 5+ years of progressive challenging QA/QC experience in pharmaceutical or related regulated industry.
• Must have an in depth knowledge of current GMP and related quality systems.
• Must possess strong communication, interpersonal skills, negotiation and problem resolution skills.
• Must be organized, detailed and have ability to handle multiple tasks at once and redirect focus based on company's needs.
• Must be able to function independently with minimal supervision.
• The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.