Description

You will perform analytical testing on raw materials, intermediates, and final products within a GMP environment.

Responsibilities

• Execute analytical methods including cell-based bioassays, Flow Cytometry, ELISA, and qPCR assays.
• Maintain laboratory instruments through regular calibration and routine maintenance.
• Review test data, in-process testing records, and documentation for drug substance and drug product release.
• Author and revise SOPs, qualification/validation protocols, and reports.
• Investigate out of specification (OOS) results and participate in root cause determination for analytical deviations.
• Monitor GMP systems to ensure compliance with documented policies and regulatory requirements.

Required Skills

• Experience with Flow Cytometry, ELISA, and PCR/qPCR assays.
• Proficiency in Quality Control testing within biotechnology or a related field.
• Knowledge of GMP systems and regulatory requirements including 21 CFR Part 11, 210, and 211.
• Ability to perform routine record reviews and support the generation of Certificates of Analysis (CoAs).
• Experience with lab investigations, identifying, writing, and closing OOS results.
• Bachelor's degree, or AA degree with 2+ years of biotechnology/QC experience, or High School degree with 3+ years of biotechnology/QC experience.

Preferred Skills

• Strong working knowledge of SOPs and quality control processes.
• Proficiency in MS Word, Excel, and PowerPoint.
• Ability to work independently with scientific and technical personnel.

Key Skills

Education

Bachelor's degree