Healthcare QA Specialist

UPS•Bensenville, IL

15d•$25 - $41

About The Position

We’re one of the world’s largest providers of transportation and logistics services. Our customers range from small and mid-sized companies up to global enterprises. Our Global Logistics and Distribution business unit provides comprehensive logistics services and warehousing solutions utilizing a global network of distribution centers, innovative technology and supply chain expertise to manage the flow of goods from receiving to storage and order processing to shipment. Job Summary The Healthcare QA Specialist (Transportation) has day to day oversite of the transportation quality systems supporting UPS Healthcare and the Ground Transportation Carrier Certification Program.

Requirements

Must be currently located in the same geographic location as the job or willing to self-relocate by yourself - Required
Bachelor’s degree in science related field (or internationally comparable degree) required - Preferred
Strong technical quality and regulatory affairs (QA/RA) knowledge
Strong computer skills
Strong verbal and written communication
Strong organization, time management and planning skills
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 - Preferred
Quality Assurance experience - Preferred
Experience with GMP and/or GDP guidelines
Experience with ISO 13485 and 9001 standards
Experience with Transportation / Supply Chain industry

Responsibilities

Implements policies, procedures and specific work instructions with internal and external stakeholders
Manages communications with internal and external stakeholders
Interacts with industry and regulatory agencies and interprets standards / regulations impacting transportation and the quality systems
Supports internal and external audits as well as facilitating and responding to client / agency audits / supplier/carrier
Remains current with applicable regulations
Liaisons with internal and external subject matter experts in changing regulation or interpretation
Liaisons with clients and other industry experts regarding industry standards and expectations.
Provides guidance and support to Business Development (BD) and Customer Solutions regarding healthcare compliance with and interpretation of regulations, including support for RFA/RFI requirements.
Supports operationally obtained certifications (e.g. CEIV, ISO etc.) as they impact the quality systems and or UPS Healthcare Compliance matters.
Conducts assessments of current UPS transportation capabilities to determine the ability to meet client requirements and proposed solutions.
Conducts risk assessment procedures and processes to minimize risk
Conducts consultations with Management to determine compliance implications of pending business opportunities.
Ensures document control systems are current and comprehensive.
Evaluates and manages procedures across locations to ensure consistency in content and implementation.
Assesses supplier/carrier questionnaire data for capability
Conducts supplier/carrier audits and produces audit reports
Develops audit improvement plans (AIP) for supplier/carriers
Supports UPS supplier/carrier relationship holder, as required, to close any AIPs
Supports all track and trending of external audit finding results
Performs annual competency evaluations of supplier/carriers
Supports the supplier/carrier approval / qualification / certification program
Supports the supplier/carrier quality and technical agreement process
Produces reports as required.
Supports carrier relations and supplier/carrier relationship holders with nonconformance and incident reporting systems related to transportation activities and the affected supplier/carrier, reviews and may approve any investigation / root cause analysis findings.
Supports the tracking and trending of nonconformance and incidents.
Ensures required quality system revisions resulting are implemented.
Integrity
Strategy Development
Problem Resolution
Multi Directional Communication
Conflict Resolution
Internal and External Stakeholder Collaboration