Specialist, Quality Control Analytical, Cell Therapy ( Wed - Saturday)

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

Role Overview - Rockville, Maryland

The Specialist, QC Analytical, performs routine and non‑routine analytical testing to support cGMP lot release and stability of cell therapy products. The role executes approved methods (e.g., flow cytometry, ELISA, PCR, automated cell counting, and other cell-based assays) with high quality and data integrity, maintains accurate documentation, and participates in laboratory investigations. The QC Specialist collaborates within the QC team and with cross‑functional partners to meet testing timelines and ensure compliant operations.

This position is for a 4 days per week, 10 hours per day shift, Wednesday – Saturday.

Role Responsibilities

• Analytical testing: Execute QC testing for cell therapy products (flow cytometry, ELISA, PCR, cell based assays, cell count/viability) 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.

Minimum Requirements

• 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.
• Demonstrate effective cross‑functional collaboration, embrace flexibility in a constantly evolving environment, and maintains a positive, solutions‑oriented attitude to drive outcomes.
• Ability to work on‑site in a lab‑based role for the assigned shift.

The annual base pay (or hourly rate of compensation) for this position ranges from $80,909.60 - $121,364.40. Our positions offer eligibility for various incentives—an opportunity to receive short‑term incentive bonuses, equity‑based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees.

In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics.

If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.