The primary focus of the QC Associate II role will be to perform GMP testing to support product lot release and in-process testing. Additionally, this role will provide technical support and troubleshooting for flow cytometry based testing.
This is a Wed - Sat AM shift (6am - 4:30pm)
- Perform routine GMP lot release and in-process testing for flow cytometry and cell biology based test methods, using various software packages for data analysis.
- Support the transfer and implementation of new analytical test method into QC Operations
- Support analytical method validation execution into a commercial setting.
- Maintain instrumentation and supporting documentation in a GMP compliant manner.
- Preparation and qualification of critical QC reagents
- Author and review QC test method and procedures as required.
- Sound understanding and knowledge of immunology and flow cytometry.
- Experience with method lifecycle in a GMP setting, including test method implementation and associated equipment onboarding.
- Demonstrated experience working with polychromatic flow cytometry panels and flow cytometry data analysis. Experience with BD FACSCantos is preferred.
- Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
- Strong analytical and communication skills
- Computer proficiency as well as strong scientific and organizational skills.
- Ability to maintain flexible intellect and adjust to a dynamic work environment.
- Experience with Quality Systems, including deviation management, laboratory investigations and change controls.
- Strong leadership skills with ability to complete projects with little to no supervision
- BS in a scientific discipline with 2+ years of regulated industrial analytical testing or QC experience, or equivalent combination of education and experience.
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