Quality Systems Specialist

Cencora; Carrollton (TX); Hybrid; USD 65,000 - 100,000; Full time

Benefits offered by this job

Comprehensive benefits

Training & development programs

Mentorship programs

Job summary

Cencora is seeking a Quality Systems Specialist to administer the electronic quality management system (eQMS) and support the continued development and implementation of Quality Systems. This role is hybrid, based in Carrollton, TX, and reports to the Supervisor, Quality Systems.

You will manage controlled documents, assist with audits, CAPA intake, and training, and collaborate with QA to improve processes across the quality system. A Bachelor's degree and 2+ years in quality are required.

Qualifications

• Bachelor's degree in a scientific field, computer science, software engineering, information systems, quality engineering, or related field, or equivalent experience.
• Experience with Quality Systems required.
• Minimum of 2 years’ experience in a Quality role – SOP management, change controls, deviation investigations and CAPAs.
• Applied knowledge of GxP, device QSR/ISO quality standards.

Responsibilities

• Manage the controlled documents (Policies, SOPs, WIs and Forms) in the eQMS and maintain them in compliance with corporate and regulatory requirements.
• Work with QA team to develop/revise QA policies and procedures.
• Serve as a secondary administrator of the eQMS for controlled documents and training assignments.
• Support training for Quality Systems processes.
• Assist the QA team with audits and reviews of controlled documents.
• Provide support for CAPA processes and intake forms.
• Track and report quality metrics related to documents, CAPAs, and improvements.
• Recommend process improvements based on trends and metrics.
• Maintain status reports for quality activities and provide to stakeholders.
• Provide guidance to eQMS users as needed.
• Collaborate with QA Managers and Director as required.
• Work under deadlines and complete tasks on time.
• Perform other projects as assigned.

Skills

eQMS administration

Quality systems knowledge

Advanced MS Office

Data analysis

Documentation control

Audit support

Communication skills

Education

Bachelor's degree

Tools

Outlook

PowerPoint

Word

Excel

Visio

Adobe Acrobat

eQMS tools

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 ourICS 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. In 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 https://www.virtualfairhub.com/cencora

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