QC Analytical Specialist – Cell Therapy (4x10h, Onsite)

AstraZeneca plc; Rockville (MD); Presencial; USD 81 000 - 121 000; Tempo parcial

Resumo da oferta

AstraZeneca plc in Rockville, MD seeks a part-time Specialist, QC Analytical to execute routine and non-routine tests for cell therapy products. The role emphasizes data integrity, instrument operation, and regulatory readiness.

The position requires a Bachelor's in a relevant science and at least 3 years of lab experience with flow cytometry, ELISA, PCR, and cell-based assays. On-site work four days a week with potential incentives and benefits.

Qualificações

• Bachelor’s degree in Biological Sciences, Chemistry, Biochemistry, or related 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, and functional cell-based assays; familiarity with associated instrumentation and software.

Responsabilidades

• Analytical testing: Execute QC testing for cell therapy products (flow cytometry, ELISA, PCR, cell based assays) per approved methods and SOPs, meeting cGMP, GDP, and ALCOA+ expectations.
• Instrument operation and maintenance: Operate, calibrate, and perform routine maintenance and troubleshooting on relevant instruments; document activities and elevate issues promptly.
• Documentation and compliance: Maintain accurate, contemporaneous records in relevant electronic systems and forms; author/review SOPs and test methods, ensure readiness for internal/external audits and regulatory inspections.
• Quality systems: Participate in laboratory investigations (e.g., OOS/OOT, deviations) by gathering data, performing preliminary assessments, and documenting findings; support implementation of CAPAs and change controls.
• Training and knowledge sharing: Complete method qualifications and maintain analyst proficiency; provide peer training on established procedures as qualified.
• Planning and teamwork: Coordinate daily testing priorities, sample receipt, and material control with the team; communicate testing status and risks to ensure on-time lot release.

Conhecimentos

Analytical testing

Cross-functional collaboration

Data accuracy

Formação académica

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

Ferramentas

Flow cytometry

ELISA

PCR

Cell counting

Descrição da oferta de emprego

AstraZeneca plc in Rockville, MD seeks a part-time Specialist, QC Analytical to execute routine and non-routine tests for cell therapy products. The role emphasizes data integrity, instrument operation, and regulatory readiness.

The position requires a Bachelor's in a relevant science and at least 3 years of lab experience with flow cytometry, ELISA, PCR, and cell-based assays. On-site work four days a week with potential incentives and benefits.