Gene Therapy QC Scientist - Level II

Job Description We are immediately hiring for a Quality Control Scientist II in the Gene Therapy field! This is a long‑term career opportunity for somebody looking to grow in the scientific field. This role will offer significant growth opportunity long‑term! This is a 1st shift opportunity. We are ideally looking for somebody who has experience working in a GMP and/or cleanroom regulated environment, but may also consider someone with similar regulated experience, such as with GLP, FDA, etc. An ideal candidate will have a Bachelors* Degree and at least 3 years of experience. This role will primarily perform a variety of documentation related work for the lab, with a focus on supporting materials release processes for gene therapy products that are used in clinical trials. The candidate will spend about 50% of their time in the cleanroom laboratory performing documentation duties, and the other 50% of the time reviewing product information for release in the shipping department, where biopharmaceutical products come in and out. This role may perform some laboratory testing as needed. Responsibilities Reviewing paperwork and materials; will need to go into a clean room to do sampling and may do some wet chemistry testing in the future. Work primarily in the Quality Department to support the testing and analysis of cGMP produced viral vectors and cells. Help support Material Release process. Performance of QC methods, development of methods, analysis of microbiological environmental monitoring samples, writing/revising SOP’s, equipment maintenance and monitoring, and materials management of QC and Production supplies. Ensure documentation is completed, reviewed, filed and archived according to Standard Operating Procedures (SOPs). Maintain compliance with applicable regulatory requirements for cellular and gene therapy products. Qualifications Bachelors Degree in a scientific field 3+ years of GMP, cleanroom, or similar experience Equal Employment Opportunity Statement The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. Reasonable Accommodation If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email View email address on click.appcast.io for other accommodation options. #J-18808-Ljbffr 6AM City, LLC