QC Analytical Specialist, Cell Therapy - 4x10h Week

AstraZeneca; Rockville (MD); Vor Ort; USD 81.000 - 121.000; Vollzeit

Zusammenfassung

AstraZeneca in Rockville, MD is seeking a Specialist, QC Analytical to perform routine and non-routine analytical testing supporting cGMP lot release and stability of cell therapy products. You will execute approved methods (flow cytometry, ELISA, PCR, automated cell counting) with high quality and data integrity, maintain documentation, and participate in investigations.

This role requires collaboration with the QC team and cross-functional partners to meet testing timelines, ensure compliant

Qualifikationen

• Bachelor's degree or higher in a relevant scientific discipline.
• Minimum of 3 years’ experience with laboratory techniques relevant to cell therapy or biologics.
• Hands-on experience with analytical methods for cell therapy or biologics, including flow cytometry, ELISA, PCR, cell culture, cell count/viability.
• Demonstrate effective cross-functional collaboration and a flexible, solution-oriented attitude.
• Ability to work on-site in a lab-based role for the assigned shift.

Aufgaben

• Analytical testing: Execute QC testing for cell therapy products per approved methods and SOPs.
• Instrument operation and maintenance: Calibrate and troubleshoot instruments; document activities and escalate issues.
• Documentation and compliance: Maintain accurate records; author/review SOPs and test methods; prepare for audits.
• Quality systems: Participate in investigations and support CAPAs and change controls.
• Training and knowledge sharing: Complete method qualifications and provide peer training as qualified.
• Planning and teamwork: Coordinate daily testing priorities, sample receipt, and material control; communicate status and risks.

Kenntnisse

Cross-functional collaboration

Regulatory compliance (cGMP, GDP, ALCO

On-site lab work

Ausbildung

Bachelor's degree in Biological Sciences, Chemistry, Biochemistry, or related discipline

Tools

Flow cytometry

ELISA

PCR

Cell culture

Cell counting/viability

Jobbeschreibung

AstraZeneca in Rockville, MD is seeking a Specialist, QC Analytical to perform routine and non-routine analytical testing supporting cGMP lot release and stability of cell therapy products. You will execute approved methods (flow cytometry, ELISA, PCR, automated cell counting) with high quality and data integrity, maintain documentation, and participate in investigations.

This role requires collaboration with the QC team and cross-functional partners to meet testing timelines, ensure compliant