Hiring for QC Analysts Level's I-III

Essential Functions And Responsibilities

• Run routine experiments such as flow cytometry, cell culture, ELISA, qPCR, endotoxin, ect.
• Performs the accurate execution of all company and/or client test methods and procedures of cellular products to ensure the safety and/or efficacy of different cell populations
• Performs maintenance, monitoring, and troubleshooting of pertinent equipment
• Performs and assists in the training of other Quality Control technicians
• Maintains training records and coordinates records retention with Document Control and Training groups
• Tests, documents, and reports results for products or materials following company and/or client procedures following CGMP and/or GTP guidelines
• Performs state proficiency testing and/or client proficiency testing under direct supervision as applicable
• Participates in managing QC materials and supplies
• Performs and assists in equipment and method qualification/validation activities as needed
• Performs reagent and media preparation
• Provides input based on level of knowledge and experience with troubleshooting malfunctioning equipment
• Investigates out-of-specification, out-of-trend, aberrant, and/or non-conforming test results
• Initiates, investigates, and prepares deviation reports with input from assigned supervisor
• Brainstorms and implements corrective and preventive actions, as and when applicable
• Completes all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)

Qualifications

• BA/BS in a science or relevant field required
• Minimum 2-5 years of experience in Quality Control laboratory setting or within the biopharmaceutical industry for level's II-III
• Prior undergrad research experience for level I