Quality Associate - Quality Operations

Cencora•Columbus, OH

About The Position

The Quality 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, including auditing production batch records throughout packaging and conducting final audits before submission to Product Release. The position also performs serialization activities, addresses product and packaging component discrepancies, carries out quality checks and testing, supports cleaning validation, and creates or updates work instructions and standard operating procedures. The Quality Associate escalates production non-conformances, leads root-cause analysis of quality incidents, participates in investigations, and drafts unplanned deviations for management review. The role works with Sampling, Label and Documentation, Production, and Warehouse teams to resolve issues and improve processes, participates in continuous improvement and internal audits, and follows cGMP, safety regulations, and SOPs. The schedule is Monday through Friday, 3:00 p.m. to 11:30 p.m., at $21 per hour.

Requirements

Completion of a high school diploma or GED.
Ability to read and understand English documents, product labels, and instructions.
Good written skills for accurately completing production-run compliance documentation.
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.
Good judgment when carrying 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, and 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 batch records.
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 production non-conformance issues, lead root-cause analysis of quality incidents, participate in investigation discussions, and draft Unplanned Deviations for management review.
Participate in technical, compliance, and other required training.
Partner with Sampling, Label and Documentation, Production, and Warehouse teams 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 requirements, safety regulations, and SOPs.
Perform other duties as assigned.