Quality Assurance Associate

The Quality Assurance Associate will be responsible for quality problem resolution at our new King of Prussia, PA manufacturing plant and will focus on continuous improvement in quality, batch review, process control and new product production.
What You Will Do:

• Issue and initiate the chain of custody for the batch record and for all labels.
• Review of batch records, labels, logbooks, test results and QC results in SAP (EBS) system within 24 hours.
• Apply Kaizen events for process enhancements, continuous improvement across multiple departments.
• Initiate and review monthly trend analyses for adjustment data to enhance process efficiency.
• Create, review SOPs, work instructions, IQ/OQ/PQ and quality-related documents.
• Lead investigations for internal and external nonconformances, ensuring product quality alignment.
• Collaborate with customers to discuss test methods for finished products, raw materials.
• Ensure all required training is completed for the QA team.
• Raise issues or non-conformances to the QA Management.
• Review of all in-process documentation.
• Perform quality inspection of logbooks and forms for all departments.

Qualifications:

• Bachelor's degree in chemistry or engineering with a chemistry component.
• 3 years' experience working in a pharmaceutical environment.
• Experience with ETQ, SAP, Veeva, QMS document management.
• Experience with Root Cause Analysis, CAPA (Corrective and preventative actions), Risk Assessment, Change Controls, Deviations, OOS/OOT.
• Understanding FDA, cGMP, GDP, ISO 9001 requirements.
• Experience with internal audits, ICH, FDA and ISO 9001.
• Shift and weekend work required as per business needs (Floater Role).

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Benefits
Ecolab strives to provide comprehensive and market-competitive benefits to meet the needs of our associates and their families. Click here to see our benefits.
If you are viewing this posting on a site other than our Ecolab Career website, view our benefits at jobs.ecolab.com/working-here.
Covid-19 Vaccine Notice
Due to local mandates and customer requirements, applicants for certain customer-facing positions must be fully vaccinated (which in some situations requires a booster if eligible), unless a religious or medical accommodation is requested by the applicant and approved by Ecolab.
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