Quality Control Associate – Night Shift

About This Role

This Associate Quality Control position involves supporting routine testing for the night shift team at a biopharmaceutical organization, working in an analytical laboratory to ensure compliance with GMP and GDP regulations.

Responsibilities

• Perform analytical testing on time-sensitive samples from Manufacturing (Titer, MMV, Mycoplasma, Endotoxin, Bioburden, TOC, Conductivity), Centralized Raw Material testing (compendial testing & microbiology), Environmental Monitoring and Critical Utilities, Sample Receipt and Aliquot
• Ensure facilities, equipment, materials, organization, processes, procedures, and products comply with safety guidelines, cGMP practices, and other applicable regulations
• Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks
• Operate laboratory equipment and instrumentation
• Perform review and approval of assays, documents, and records
• Support troubleshooting and problem solving
• Alert management of quality, compliance, supply, and safety risks
• Support TRAs and deviations, as applicable
• Complete required assigned training to permit execution of required tasks

Requirements

• Experience with analytical laboratory testing
• Ability to plan and perform routine tasks with efficiency and accuracy
• Demonstrated ability to work independently and deliver right first time results
• Excellent communication skills (written and verbal)
• Focus on data integrity
• Experience with HPLC, Microbiology, and Wet Chemistry testing
• Knowledge of GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices)
• Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories
• Understanding of biopharmaceuticals process and related unit operations
• Strong analytical skills with the ability to collect, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy

Qualifications

• High school/GED + 2 years work experience or Associate's degree and 6 months work experience or Bachelor's degree
• 2 years work experience with a high school diploma/GED, or 6 months with an Associate's degree, or no specific experience with a Bachelor's degree.

Skills

* Required skills