Job Description

Seeking an experienced Quality Control Analyst to support cGMP manufacturing operations. In this role, you will perform routine and complex QC testing, review assay data, troubleshoot issues, and ensure compliance with all regulatory and company quality standards. You will support in-process, finished product, raw materials, and environmental monitoring testing, along with method validation, equipment maintenance, and audit readiness.

Shifts:

• Sun–Wed OR Wed–Sat (4×10 schedule)

• Day: 6:30 AM – 5:00 PM

• Swing: 11:30 AM – 10:00 PM

Responsibilities:

• Perform routine QC testing and environmental monitoring in a cGMP lab.
• Review data, troubleshoot assay/equipment issues, and document results per cGMP.
• Support method validation, method transfer, and equipment calibration.
• Maintain inspection readiness and support audits.
• Collaborate across teams and act as SME for QC procedures.

Requirements:

• Bachelor’s degree in Life Sciences + 3+ years cGMP QC experience.
• Strong aseptic technique and hands-on lab testing experience.
• Ability to analyze data, solve problems, and work independently.
• Excellent communication and documentation skills.
• Ability to lift up to 25 lbs and work on feet for extended periods.

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