Job SummaryThe 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.
ResponsibilitiesFacilitates 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 InformationWe offer an excellent salary and benefits package including medical, dental and vision 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 permanent employment arrangement. All employment is at-will, 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.
