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