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Job Details

Shift Hours:

Sunday-Thursday 11pm-7:30am

This role is in support of American Health Packaging, a Cencora business offering pharma packaging services in the US.  

The Quality Operations Associate provides guidance and direction to daily Quality and Production activities to maintain compliance with corporate and regulatory requirements. 

• 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. 

Education & Experience: 

• 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. 

Skills & Knowledge: 

• 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. <