Description

You will perform analytical testing and maintain laboratory compliance on a swing shift (Wednesday–Saturday, 1:00 pm – 11:30 pm).

Responsibilities

• Execute testing of raw materials, intermediates, and final products using cell-based bioassays, flow cytometry, ELISA, and qPCR assays.
• Maintain laboratory instruments through routine calibration and maintenance.
• Monitor and trend data, performing routine record reviews for in-process testing, drug substance, and drug product release.
• Author and revise SOPs, qualification/validation protocols, and reports.
• Assist with lab investigations regarding 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

• Bachelor’s Degree, OR an AA Degree with 2+ years of biotechnology/QC experience, OR a High School Diploma with 3+ years of biotechnology/QC experience.
• Experience with Flow Cytometry, ELISA, and PCR.
• Knowledge of GMP, SOPs, and quality control processes.
• Familiarity with 21 CFR Part 11, 210, and 211 regulatory requirements.
• Proficiency in MS Word, Excel, and PowerPoint.
• Ability to work independently with scientific and technical personnel.

Preferred Skills

• Experience in the biotechnology or pharmaceutical industry.
• Direct experience identifying, writing, evaluating, and closing OOS investigations.

Key Skills

Education

Bachelor's degree