Job Description

The Quality Assurance / Quality Control Analyst will be responsible for quality problem resolution at our facility in Philadelphia, Pa manufacturing plant and will focus on continuous improvement in quality, batch review, process control and new product production. This job requires working onsite, five days weekly.

What You Will Do :

• Review of batch records, labels, logbooks, test results and QC results.
• Review test reports and generate Certificate of Analysis.
• 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, and other quality-related documents.
• Ensure all required training is completed for the QA team.
• Raise issues, deviations or non-conformances to the QA Management.
• Lead investigations for internal and external nonconformances, ensuring product quality alignment.
• Review of all in-process documentation.
• Perform quality inspection of logbooks and forms for all departments.
• Track and trend site Quality data.
• Conduct inspections and audits to ensure compliance with internal quality standards and regulatory requirements.
• Help facilitate GDP (good documentation practices).

Qualifications :

• Bachelor's degree in Chemistry, Biology, or Engineering.
• 3+ years working in a manufacturing environment.
• Ability to communicate/collaborate across all levels of management and associates.
• Business level knowledge in Outlook, Word, Excel, PowerPoint, Microsoft Teams etc.

Preferred Qualifications

• Experience with ETQ, SAP, QMS document management.
• Experience with Root Cause Analysis, CAPA (Corrective and preventative actions), Non-conformances/OOS, Change Controls, Deviations.
• Familiarity with ISO 9001.
• Previous experience working in GDP/GMP environments.

Compensation:

$65-85K/hr

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

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