Category: Scientific & Clinical
Title: Quality Specialist
Location: West Point, PA
Schedule: 8am to 5pm Mon – Fri.
Start date: ASAP
- The Quality Specialist will be responsible for supporting Critical Reagent programs in a fast-paced environment within the Vaccine franchises.
- The support is critical to testing within the Quality Control Laboratories.
- This position requires experience in general cell biology and either virology or biochemistry techniques.
- Under the guidance of a Manager, the position requires experience in virology and biochemistry techniques including ELISA, antibody production, cell culturing, QPCR and cell line expansions.
- The Quality Specialist is responsible for independently managing the complete lifecycle of Critical Reagents such as; reference materials, positive controls, anti-sera and other critical materials.
- In addition, the Specialist will be responsible for independently managing the complete lifecycle of Critical Reagents such as; reference materials, positive controls, anti-sera and other critical materials.
- Release and stability testing of vaccine and biological products use these reagents.
- Reagent lifecycle includes; acquisition, certification and qualification testing, implementation and ongoing monitoring and replacement of the material as needed.
- Additionally, the individual will work independently and demonstrate leadership in the implementation, execution and management of reagents, as well as perform appropriate second person peer document reviews, support activities and project work associated with their position, and ensure work is conducted to the highest quality, compliant and conforms to current Good Manufacturing Practices and regulatory expectations.
- Provide bioanalytical support to Global MMD sites as needed and respond to regulatory questions, author of analytical license sections and support regulatory inspections.
- B.S. in Biochemistry, Virology or related biological science
- Bachelor's Degree with a minimum 4 years' of laboratory experience.
- Demonstrated leadership and teamwork skills and ability to work independently.
- Strong technical knowledge and high level of technical performance.
- Laboratory experience, knowledge of laboratory operations and bioanalytical instrumentation.
- Previous technical and/or analytical problem solving experience in vaccine or biologics development, and/or quality site experience.
- Proficiency in classical biochemistry or virology assays.
- Experience in the following assays: ELISA, PCR, RNA Extractions, TCID50 assays, virus tittering, serum neutralization assays, plaque assays, cell culturing, Ouchterlony, cell banking
- GMP experience.
- Statistical analysis experience with familiarity with JMP.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.