Qa specialist serp_jobs.h1.location_city

Job Summary

The QA Complaint Specialist is responsible for working with Quality Complaint Intake Team (Regional QA), US Vigilance & other departments to facilitate the completion of investigations of quality complaints, service (shipping) complaints and manufacturing site ADE investigations, along with the review and closure of documentation, for third party manufactured products.

This position impacts all US Third Party Manufacturing (TPM) and Supply Chain (SC) Quality activities relative to investigations of product quality complaints, which ensure the facility's GMP / FDA compliance status. It is essential that

duties are performed promptly and accurately with special attention to each incident as the product's safety, quality, identity, purity, and potency could be impacted. Must be able to effectively work with all levels of personnel within Fresenius Kabi USA, Fresenius Kabi partners, and with FK-USA's third party manufacturing contacts and lead meetings / communications with internal and external partners.

• Due to applicable export control laws and regulations, candidates must be a U.S. citizen or national, U.S. permanent resident (e.g., current Green Card holder), or lawfully admitted into the U.S. as a refugee or granted asylum.
• Salary Range : $62,000-$70,000
• 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

o Monitors complaint intake to ensure initial impact assessment is completed within 3 days of awareness for product quality complaints and within 5 days of awareness for service (shipping) complaints.

o Proactively manages complaint record timelines to meet 60 day target for product quality complaints and 30 day target for shipping complaints. If record extension is needed, requests in a timely manner.

o Participates in cross functional internal / external team meetings to discuss lot and CPM trends and documents agenda, action items and outcome.

o Proactively identifies and communicates negative trends.

Requirements

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.

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.