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.
Job Description
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.
- 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
Quality Control Scientist II
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