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 deparments 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
- Additional tasks as needed
Requirements
· Bachelor's degree in the sciences with 5+ years of progressive challenging QA/QC experience in pharmaceutical or related regulated industry is required.
· Must have an in depth knowledge of current GMP and related quality systems.
· Requires 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.
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 match, and wellness program.
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.
What We Do
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients.
Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face.
Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders.
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