Healthcare QA Specialist

UPS•Miami, FL

2d•Onsite

About The Position

This position is with Marken, UPS Healthcare Precision Logistics, which is the clinical and advanced therapy part of UPS Healthcare. The organization focuses on reaching patients faster with greater scalability and access to new pathways throughout the supply chain, leveraging the One UPS advantage and a comprehensive service portfolio including Polar Speed's in-network pharmacies. The Healthcare QA Specialist monitors the overall Quality System status of the distribution center, ensuring compliance with drug, medical device, and local regulations. The role involves maintaining quality processes through the implementation of procedures, training, and regular inspections.

Requirements

Must be a U.S. Citizen or National of the U.S., an alien lawfully admitted for permanent residence, or an alien authorized to work in the U.S. for this employer.

Nice To Haves

Pharmaceutical, healthcare or food industry experience
Quality Assurance experience
Bachelor’s Degree in Science related field (or internationally comparable degree)
QPIC/AQPIC designation

Responsibilities

Ensures all staff is trained in their respective job functions, including GMP.
Writes and revises Standard Operating Procedures as required.
Conducts regular inspections of the facility and recordkeeping, including summarization and reporting of findings.
Coordinate or assist with corrective actions and preventative measures.
Communicates with clients and provides information during external audits
Liaises with Health Canada officials during regulatory audits.
Provides feedback and assistance to Customer/Client QA related questions and concerns.
Monitors the processes and systems within the Department to ensure regulatory compliance and effective operation.
Investigates discrepancies and problems, and advise the appropriate individuals of the findings.
Assists in development of pro-active strategies as a preemptive measure against potential future problems with systems or processes.
Completes NCR reports and change control requests and provide necessary follow-up.
Performs maintenance, support, and continuous improvements of Quality Systems.
QPIC designation duties.