Sr QA Supplier Specialist

Fresenius Group; Melrose Park, Northern (IL, KY); Hybrid; USD 98,000 - 113,000; Full time

Job summary

Fresenius Kabi in Melrose Park, IL seeks a Sr QA Supplier Specialist to support regulatory, ISO and global compliance. You will ensure supplier management and internal audit processes meet procedures, with no supervisory responsibilities.

Salary range is $98-113K with a 6% bonus target; comprehensive benefits include a 401(k), vacation, holidays, health coverage and EAP. Applicants must be authorized to work in the U.S.; visa sponsorship is not offered.

Qualifications

• Bachelor's degree in the sciences; 5+ years of QA/QC experience in pharma or related regulated industry.
• In-depth knowledge of current GMP and related quality systems.
• Strong communication, interpersonal, negotiation and problem-solving skills.
• Organized, detail-oriented with ability to multitask and adapt to needs.
• Ability to work independently with minimal supervision.

Responsibilities

• Facilitates supplier management activities and supports qualification of new and existing suppliers.
• Collaborates with cross-functional groups to complete supplier qualification activities.
• Interfaces with suppliers for audits (on-site, virtual, hybrid, or document) and requests qualification documentation.
• Performs supplier (re)qualification audits.
• Collects and reviews supplier (re)qualification documentation.
• Prepares supplier (re)qualification reports or evaluation reports.
• Updates regional and global supplier tracking databases and reports.
• Assists team with supplier qualification activities as needed.
• Supports internal, regional, and global departments with supplier questions/requests.
• Manages and maintains Approved Vendor List.
• Facilitates Regional internal audit program; ensures audits are scheduled, conducted, closed.
• Participates as Lead/Co-auditor in internal audits and drafts audit reports.

Skills

QA/QC experience

GMP knowledge

Communication skills

Organizational skills

Independent work

Education

Bachelor's degree in the sciences

Job description

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

• 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.

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.

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 andvision coverage, as well as life insurance, disability, 401K with company contribution,and wellness program.

Please note that joining our team does not create a guaranteed or permanentemployment arrangement. All employment is at-will, meaning both the employeeand 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 applicantswill receive consideration for employment without regard to race, color, religion, sex, national origin,citizenship, immigration status, disabilities, or protected veteran status.