Sr QA Supplier Specialist

Fresenius Kabi USA, LLC; Melrose Park (IL); Sur place; USD 98 000 - 113 000; Plein temps

Avantages offerts par ce poste

401K with company contributions

Medical, dental and vision coverage

Life insurance

Disability insurance

Wellness program

Résumé du poste

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

Qualifications

• 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.

Responsabilités

• 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

Connaissances

GMP knowledge

QA/QC experience

Communication skills

Problem solving

Organization

Formation

Bachelor's degree in the sciences

Description du poste

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.