Scientist, QC Analytical

$74,080 - $101,860/Yr

Disability Solutions - Severn, MD

Full-time - Entry Level

Severn, MD

About the position

The Scientist, QC Analytical is responsible for supporting analytical testing to ensure compliance with GMP manufacturing for clinical and commercial clients. This role requires technical knowledge, familiarity with scientific and regulatory principles, and a commitment to scientific excellence. The position involves performing various assays and documenting testing procedures, contributing to the quality control of pharmaceutical products.

Responsibilities

• Perform assays such as ELISA, DNA/RNA extraction, gel electrophoresis, qPCR, ddPCR, HPLC, and Capillary Electrophoresis.
• Document testing per GMP/GDP procedures.
• Generate internal and external documents such as assay protocols, summary reports, and 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 intermediate/finished products.
• Review laboratory work and approve data packages as designated by the Supervisor.
• Provide instrumentation care, maintenance, troubleshooting, and data interpretation.
• Responsible for document writing including laboratory investigations, out of specifications, deviations, and CAPAs.

Requirements

• Bachelor's degree in a Life Sciences discipline with 2-4 years of experience in a cGMP QC laboratory, or a Master's degree in a Life Sciences discipline with 0-2 years of experience.
• Experience with techniques such as ELISA, qPCR, ddPCR, HPLC, and Capillary Electrophoresis.
• Knowledge of QC analytical methods used for protein chemistry and molecular biology.
• Experience in the biologic, pharmaceutical, or medical device industry with a strong familiarity of general GMP practices.
• Experience in writing SOPs.

Nice-to-haves

• Experience in a fast-paced laboratory environment.
• Familiarity with statistical analysis and trending.

Benefits

• Competitive medical benefits
• 401K
• 152 hours PTO
• 8 Paid Holidays
• Opportunity to work on Continuous Improvement Processes