QC Microbiology Associate – Cell Therapy, On‑Site & Growth

AstraZeneca plc; Rockville (MD); Presencial; USD 56.000 - 84.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Qualified retirement programs

Paid time off (vacation, holiday, and…

Descripción de la vacante

AstraZeneca plc is seeking a Senior Laboratory/QA support role in Rockville, MD to ensure safety, sterility, and regulatory compliance of raw materials and products. Learn and perform routine lab activities with high data integrity, assist QC operations, and maintain regulatory standards to support clinical and commercial manufacturing.

Role emphasizes ALCOA+ data practices, environmental monitoring, and collaboration across teams to meet lot release timelines.

Formación

• Associate or degree in biological sciences with relevant lab experience.
• Experience in pharmaceutical/biotech QC or regulated documentation preferred.
• Ability to follow SOPs precisely and maintain regulatory standards.
• Strong right-first-time execution and accurate record-keeping.
• On-site lab-based role with 4/10 schedule Sun-Wed.

Responsabilidades

• Perform environmental monitoring sampling across GMP spaces.
• Gown certification for Grade D, C, B environments to support EM.
• Incubate and enumerate media plates and samples.
• Dispatch samples to external labs for identification.
• Operate instruments per SOPs with daily checks and calibrations.
• Assist routine testing (Sterility, Mycoplasma, Bioburden, Endotoxin, growth, and cell aliquoting).
• Record data in electronic systems per ALCOA+ guidelines.
• Maintain inventory and perform 5S housekeeping; support sample logistics.
• Document deviations and assist investigations; support CAPAs.
• Communicate testing status and coordinate scheduling to meet lot releases.

Conocimientos

ALCOA+ data integrity

GMP/compliance understanding

SOP adherence

Cross-functional collaboration

Educación

Associate’s degree in Biological Sciences or related

Bachelor’s degree with minimum 3 months experience

Herramientas

LIMS (MODA, 1Lab)

Descripción del empleo

AstraZeneca plc is seeking a Senior Laboratory/QA support role in Rockville, MD to ensure safety, sterility, and regulatory compliance of raw materials and products. Learn and perform routine lab activities with high data integrity, assist QC operations, and maintain regulatory standards to support clinical and commercial manufacturing.

Role emphasizes ALCOA+ data practices, environmental monitoring, and collaboration across teams to meet lot release timelines.