Quality Systems Specialist

Integrated Commercialization, LLC; Carrollton (TX); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical insurance

Dental

Vision care

Backup dependent care

Adoption assistance

Infertility coverage

Family building support

Behavioral health solutions

Paid parental leave

Paid caregiver leave

Training programs

Professional development resources

Mentorship programs

Volunteer activities

Job summary

Cencora in Carrollton, TX is seeking a Quality Systems Specialist who will manage the eQMS, maintain controlled documents (SOPs, WI, forms) and support QA policies. This role blends document control, deviation tracking and CAPA facilitation with data-driven reporting for management reviews.

You will train users, assist with internal and client audits, and partner with the QA team to drive continuous improvements, meeting regulatory requirements and corporate standards while working in a hybrid

Qualifications

• Bachelor's degree in a related field with 2+ years in quality.
• Experience with SOP management, change controls, deviation investigations and CAPAs.
• Applied knowledge of GxP or ISO quality standards.

Responsibilities

• Administer the eQMS and maintain controlled documents (SOPs, WI, forms).
• Monitor deviations, audit findings, and CAPA processes.
• Support QA training, audits, and data reporting for management review.
• Provide guidance to eQMS users and collaborate with QA team.

Skills

Quality Systems

SOP management

CAPA process

Data reporting

Training support

Collaboration

Education

Bachelor's degree in science/engineering

Quality systems experience

GxP/ISO knowledge

Tools

eQMS

MS Office (Outlook, Word, Excel, PowerPoint)

Visio

Adobe Acrobat

Job description

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.

Job Details

This role is in support of Cencora's 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, 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.

Education & Experience

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.

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.

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day.

• medical
• dental
• vision care

We also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness.

• backup dependent care
• adoption assistance
• infertility coverage
• family building support
• behavioral health solutions
• paid parental leave
• 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.

• training programs
• professional development resources
• mentorship programs
• employee resource groups
• volunteer activities

For details, visit https://www.virtualfairhub.com/cencora

Full time

Equal Employment Opportunity

Full time Equal Employment Opportunity 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 company’s 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 [e-mail]. We will make accommodation determinations on a request‑by‑request basis. Messages and emails regarding anything other than accommodations requests will not be returned.

Affiliated Companies

Affiliated Companies: Integrated Commercialization, LLC