Healthcare QA Specialist
About The Position
Together, we are Marken, UPS Healthcare Precision Logistics. As the clinical and advanced therapy part of UPS Healthcare, we reach patients faster, with greater scalability and access to new pathways throughout the supply chain. With our One UPS advantage and comprehensive service portfolio, including Polar Speed's in-network pharmacies, we are optimally positioned to keep our clients competitive in an increasingly complex market. This position monitors the overall Quality System status of the distribution center. This position acts in compliance to drug, medical device, and local regulations. Ensures quality processes are maintained 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.
Benefits
- Medical/prescription drug coverage
- Dental coverage
- Vision coverage
- Flexible Spending Account
- Health Savings Account
- Dependent Care Flexible Spending Account
- Basic and Supplemental Life Insurance & Accidental Death and Dismemberment
- Disability Income Protection Plan
- Employee Assistance Program
- 401(k) retirement program
- Vacation
- Paid Holidays and Personal time
- Paid Sick and Family and Medical Leave time as required by law
- Discounted Employee Stock Purchase Program
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
