Senior QA & Supplier Compliance Auditor

Fresenius Kabi USA, LLC; Melrose Park (IL); Vor Ort; USD 98.000 - 113.000; Vollzeit

Benefits dieser Stelle

401K with company contributions

Medical, dental and vision coverage

Life insurance

Disability insurance

Wellness program

Zusammenfassung

Fresenius Kabi USA, LLC seeks a Sr QA Supplier Specialist to support supplier management, internal audits, and regulatory compliance. You will coordinate supplier qualification, audits, and documentation while maintaining regional and global databases.

Collaboration across functions ensures quality agreements and continued supplier performance. The role requires a Bachelor's in the sciences with 5+ years of progressive QA/QC experience in a regulated pharmaceutical environment and strong GMP

Qualifikationen

• Must have 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 able to handle multiple tasks with minimal supervision.

Aufgaben

• 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 audits
• 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 and global 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 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
• Executes or supports inter-company quality agreement
• 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 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

Kenntnisse

GMP knowledge

QA/QC experience

Communication skills

Problem solving

Organization

Ausbildung

Bachelor's degree in the sciences

Jobbeschreibung

Fresenius Kabi USA, LLC seeks a Sr QA Supplier Specialist to support supplier management, internal audits, and regulatory compliance. You will coordinate supplier qualification, audits, and documentation while maintaining regional and global databases.

Collaboration across functions ensures quality agreements and continued supplier performance. The role requires a Bachelor's in the sciences with 5+ years of progressive QA/QC experience in a regulated pharmaceutical environment and strong GMP