Quality Systems Specialist

Cencora•Carrollton, TX

5d•Hybrid

About The Position

This role is in support of Cencora's third party logistics service in the US operating through our ICS business. This is a hybrid role that will work out of our Carrollton Office and our future DFW Distribution Center. Under the general direction of the Supervisor, Quality Systems, the Quality Systems Specialist is primarily accountable for the administration of the electronic quality management system (eQMS) to support the continued development, improvement and implementation of Quality Systems. This is an individual contributor position responsible for maintaining, monitoring the effectiveness of, and providing improvements for, various Quality System program activities including control of documents (e.g., SOPs), tracking & trending deviations & audit findings, facilitation of CAPAs, and creation of Quality System trend reports for Management Review.

Requirements

Bachelor's degree (preferably in scientific discipline ,computer science, software engineering, information systems, quality engineering, or a related field, or equivalent experience required.).
Experience with Quality Systems required.
Minimum of 2 years’ experience in a Quality role – specifically in SOP management, change controls, deviation investigations and CAPAs.
Applied knowledge of pharmaceutical Good Regulated Practices (GxP’s) or device Quality System Regulations or ISO quality standards.
Advanced proficiency in the use of computerized systems to effectively administer the specialized electronic quality management system (eQMS) applications, as well as efficiently utilize common office applications (e.g., Outlook, PowerPoint, Word, Excel, Visio and Adobe Acrobat).
Exceptional quality of work and attention to detail.
High level of organization, time-management and prioritization skills, with the ability to manage a number of projects with tight timelines and minimal supervision.
Motivated self-starter with the ability to proactively investigate solutions and provide recommendations to Manager for discussion.
Efficient in compiling, managing and interpreting data from various sources (e.g. from audits, complaints, non-conformances, etc.).
Excellent interpersonal, written and verbal communication skills.
Refined strategic, collaboration and presentation skills.
Team player who respects all functional levels internally and externally.

Responsibilities

Manage the controlled documents (Policies, SOP’s, WI’s and Forms) in the eQMS and maintain them in compliance with corporate and/or regulatory requirements.
May perform the roles of document Author, Reviewer, and/or Approver.
Work with the QA team in the development/revision and implementation of QA policies and procedures as required.
Serve as a secondary (back-up) administrator of the eQMS for controlled documents, assignment of training, profile updates, vault creation, obsolescence of documents, etc.
Support training for Quality Systems processes as needed.
Assist the QA team with audits (internal, client, etc.), reviews of controlled documents, etc. as required.
Provide support and consultation on the CAPA process, including the CAPA-intake processes and forms (such as deviations, nonconformances, complaints, audits, etc.).
Follow-up and provide data required for key performance quality metrics related to controlled documents, CAPAs, and continuous quality improvements.
Recommend organizational process improvement initiatives based on identified trends and key performance quality metrics.
Maintain status reports for quality systems activities and provide to stakeholders as scheduled/requested.
Support the Business Process Owners (BPOs) in providing technical, procedural, and compliance-based guidance to eQMS users as needed.
Provide assistance to the QA Managers and QA Director as required.
Work under challenging deadlines and be accountable for completing work within specified time periods.
Perform other projects as assigned by manager.