Packaging QA Associate

Cencora•Columbus, OH

About The Position

The Packaging QA Associate supports Cencora's U.S. distribution services operating through its AmerisourceBergen business. The role provides direction and guidance to daily quality assurance and production activities, ensuring packaging work meets applicable quality and compliance requirements. The schedule is Monday through Friday, 3:00 p.m. to 11:30 p.m., with pay of $21 per hour. The associate audits production batch records during packaging and conducts final audits before submission for product release. The role also performs serialization activities, resolves discrepancies involving non-controlled products and packaging components, completes quality in-process checks and testing, and supports cleaning validation. It creates, reviews, and updates work instructions and standard operating procedures; escalates non-conformances; and helps investigate quality incidents and prepare unplanned deviations. The position works with Sampling, Label and Documentation, Production, and Warehouse teams to resolve issues and improve processes. It also participates in internal audits, continuous improvement activities, and required technical and compliance training, while adhering to current Good Manufacturing Practices, safety regulations, and SOPs.

Requirements

High school diploma or GED.
Ability to read and understand English-language documents, product labels, and instructions.
Good written skills to accurately complete compliance documentation for production runs.
In-depth knowledge of the function and basic problem-solving capabilities for troubleshooting production issues.
Basic mathematical skills.
Strong interpersonal skills and ability to develop and maintain cooperative working relationships.
Strong organizational skills and attention to detail.
Ability to use good judgment to carry out detailed instructions.
Ability to work independently and handle multiple tasks simultaneously.
Good verbal and written communication skills.
Computer literacy, including ERP systems, Microsoft Office (Outlook, Word, and Excel), and computer-based training.

Responsibilities

Provide direction and guidance to daily QA and production activities.
Audit production batch records throughout the packaging process for accuracy and compliance.
Conduct final audits before submitting records to Product Release.
Perform serialization activities, including sending print, releasing, suspending, and cloning work orders to support production needs.
Verify and correct non-controlled product and packaging component discrepancies in applicable systems.
Ensure applicable deviations and supporting documentation are included in the batch record.
Perform quality in-process checks as needed.
Perform Specific Gravity testing and TOC analysis.
Perform Cleaning Validation swabbing at the request of the Stability department.
Create, review, and update work instructions and SOPs applicable to daily activities.
Escalate non-conformance issues during production and lead root cause analysis of quality incidents.
Participate in investigation discussions and draft Unplanned Deviations for management review.
Participate in required technical, compliance, and other quality-team training.
Partner with Sampling, Label and Documentation, Production, and Warehouse to resolve issues and improve processes.
Participate in continuous improvement activities to increase efficiency and team member engagement in the production area.
Participate on the site internal audit team representing QA Production.
Adhere to cGMP, safety regulations, and SOPs.
Perform other duties as assigned.