Scientist, QC Analytical

About This Role

This role supports analytical testing for GMP manufacturing of clinical and commercial products, requiring strong technical knowledge and familiarity with scientific and regulatory principles. The Scientist, QC Analytical will contribute to maintaining high-quality standards in testing and documentation.

Responsibilities

• Perform assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, ddPCR, HPLC, Capillary Electrophoresis, Appearance, Osmo, and pH
• Document testing in compliance with GMP/GDP procedures
• Generate internal and external documents such as assay protocols, summary reports, and standard operating procedures (SOPs)
• Provide analytical support to QC method services for method verification of platform test methods
• Support release and stability testing for raw materials, components, standards, and finished products
• Review laboratory work and approve data packages as designated by the Supervisor
• Maintain and troubleshoot instrumentation, ensuring accurate data interpretation
• Write laboratory investigations, out-of-specification reports, deviations, corrective and preventive actions (CAPAs), and perform statistical analysis and trending
• Review paper and electronic records for accuracy and compliance
• Report issues to management and participate in issue resolution and investigations
• Work under general supervision to meet project goals and adapt to off-hour or weekend work as needed
• Participate actively in training activities and manage individual training plans
• Perform other duties as assigned

Requirements

• Bachelor’s degree in a Life Sciences discipline with at least 2 years of experience in a cGMP QC laboratory, or a Master’s degree in a Life Sciences discipline with at least 1 year of experience in a cGMP QC laboratory
• Experience in the biologic, pharmaceutical, or medical device industry performing hands-on QC work with strong familiarity with GMP practices
• Experience in writing standard operating procedures (SOPs)
• Strong foundation in biochemistry with hands-on experience reviewing documentation and applying scientific and regulatory principles to support quality and operational activities
• Demonstrates excellent attention to detail, organizational skills, and the ability to work effectively in fast-paced, team-oriented environments
• Proficient in Microsoft Excel and Word, leveraging these tools to manage documentation, analyze data, and support business processes
• Ability to work a set shift with occasional overtime as required

Nice to have:

• Experience with techniques such as ELISA, qPCR, ddPCR, HPLC, and Capillary Electrophoresis