Quality Operations Associate

Cencora•Columbus, OH

About The Position

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! Job Details Summary: Reporting to the Manager of Quality Assurance, the QA Associate – Quality Operations provides guidance and direction to daily Quality and Production activities to maintain compliance with corporate and regulatory requirements. This job position is compliance critical, and responsibilities include ensuring continual and proper compliance with all division, corporate, and government regulatory requirements. It is the Team Members responsibility to observe all safety rules. Any condition thought to be hazardous or unsafe should be reported to your supervisor immediately. Work hours: Sunday - Friday -- 11pm -7:30 am EST

Requirements

Requires completion of a high school diploma, general education degree (GED) or equivalent combination of experience and education
Requires five or more (5+) years of equivalent work experience.
Familiar with quality assurance concepts, practices and procedures in packaging of pharmaceuticals
Ability to read and understand the English language for the purpose of reading documents, product labels and instructions
Must have good written skills for the purpose of accurately completing compliance documentation for production runs
In-depth knowledge of the function and basic problem-solving capabilities for the purpose of troubleshooting issues during production activities
Must possess basic mathematical skills
Strong interpersonal skills; ability to develop and maintain cooperative working relationships with others
Strong organizational skills as well as detail oriented
Ability to use good judgement in order to carry out detailed instructions
Ability to work independently and handle a variety of tasks simultaneously.8. Good verbal and written communication skills
Computer literate with ERP Systems, Microsoft Office (Outlook, Word, Excel) and computer-based training

Responsibilities

Provides direction and guidance to daily QA and Production activities
Could include but not limited to the following activities: Audits production batch records throughout the packaging process for accuracy and compliance
Conducts final audit prior to submitting to Product Release
Performs serialization activities, including but not limited to sending print, releasing, suspending, and cloning a work order to support production needs
Verifies and corrects non-controlled product and packaging component discrepancies within the applicable systems
Ensures applicable deviations and supporting documentation is provided in the batch record
Performs Quality in-process checks as needed
Performs Specific Gravity testing and TOC analysis
Performs Cleaning Validation swabbing upon the request of the Stability department
Creates, Reviews and Updates WIs and SOPs applicable to daily activities
Escalates non-conformance issues during the production process to management and leads the root cause analysis of quality incidents, participates in investigation discussions, and drafts Unplanned Deviations prior to submitting it for management review
Actively engages in all technical training, as well as compliance and other training required as a member of the quality team
Works in partnership with supporting areas (Sampling, Label and Documentation, Production, Warehouse) to resolve issues and improve processes by participating in continuous improvement activities to increase efficiency and Team Member engagement in the production area
Participates on the site internal audit team representing QA Production
Adheres to all cGMP, safety regulations, and understands SOP's
Performs all other duties as assigned

Benefits

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.

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