Sr QA Supplier Specialist

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

Benefits dieser Stelle

Bonus plan: 6% target of base salary

401(k) with company contributions

Paid vacation, holidays and personal/P

Health benefits: medical, prescription

Dental and vision coverage

Employee assistance program

Wellness program

Zusammenfassung

Fresenius Kabi USA, LLC seeks a Sr QA Supplier Specialist to support regulatory, ISO and global compliance across supplier management and internal audit activities. This role involves audits (on-site, virtual, hybrid or document), supplier qualification, and maintaining supplier databases to ensure quality across the network.

The position offers a bonus plan with a target of 6% of base salary and a comprehensive benefits package including a 401(k) with company contributions, paid time off, and

Qualifikationen

• Bachelor's degree in the sciences with 5+ years of QA/QC in pharmaceutical or regulated industry.
• Solid knowledge of current GMP and related quality systems.
• Strong communication, interpersonal, negotiation and problem resolution skills.
• Highly organized, detail oriented and able to handle multiple tasks.
• Ability to function independently with minimal supervision.

Aufgaben

• Facilitates supplier management activities and qualification of new and existing suppliers.
• Collaborates with cross-functional groups to complete supplier (re)qualification.
• Interfaces with suppliers for audits and requests (re)qualification docs.
• Performs supplier (re)qualification audits and reviews documentation.
• Prepares supplier (re)qualification reports and evaluations.
• Maintains regional and global supplier tracking databases.
• Supports internal, local, regional, and global departments on supplier questions.
• Manages and maintains Approved Vendor List.
• Supports regional internal audit program and audit scheduling.
• Participates as Lead or Co-auditor in internal audits.
• Plans and conducts internal audits and drafts audit reports.
• Coordinates quality agreements with suppliers and internal entities.
• Maintains regional and global Quality Agreement databases.
• Assists in monthly management reviews and APQR data preparation.
• Supports inspections and quality programs related to suppliers.

Kenntnisse

QA/QC knowledge

GMP knowledge

Communication skills

Organizational skills

Independent worker

Ausbildung

Bachelor's degree in the sciences

Jobbeschreibung

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.

Salary Range: $98-113K based on experience

Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.

• Position is eligible to participate in a bonus plan with a target of 6% of the base salary (include only if applicable to the grade level)
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

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.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.