Quality Systems Specialist
Job Location:
Carrollton, TX - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Our team members are at the heart of everything we do. At Cencora we are united in our responsibility to create healthier futures and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
This role is in support of Cencoras third party logistics service in the US operating through our ICS business.
Location: 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.
Manage the controlled documents (Policies SOPs WIs 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
Education & Experience:
Bachelors 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 (GxPs) or device Quality System Regulations or ISO quality standards.
Skills & Knowledge:
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.
We provide compensation benefits and resources that enable a highly inclusive culture and support our team members ability to live with purpose every addition to traditional offerings like medical dental and vision care we also provide a comprehensive suite of benefits that focus on the physical emotional financial and social aspects of wellness. This encompasses support for working families which may include backup dependent care adoption assistance infertility coverage family building support behavioral health solutions paid parental leave and paid caregiver leave. To encourage your personal growth we also offer a variety of training programs professional development resources and opportunities to participate in mentorship programs employee resource groups volunteer activities and much more. For details visit time Cencora is committed to providing equal employment opportunity without regard to race color religion sex sexual orientation gender identity genetic information national origin age disability veteran status or membership in any other class protected by federal state or local law. The companys continued success depends on the full and effective utilization of qualified individuals. Therefore harassment is prohibited and all matters related to recruiting training compensation benefits promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment please call 888.692.2272 or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
Required Experience:
IC
About Company
Discover how Cencora delivers innovative cell and gene therapy solutions, enhancing patient access, affordability, and connectivity across treatment journeys.
