QC Specialist – Global Cell Therapy Raw Materials

Position Summary

We are seeking aQC Specialistto supportraw material qualification testing and releaseacross theCell Therapy network. This roleis responsible formethod developmenttechnical transferanalytical testing andmaterial releaseactivities to ensure raw materials used in manufacturing meet required standards forquality safety and regulatory compliance.This role will support multiple clinical manufacturing facilitiesat AstraZenecasRockville MD and Gaithersburg MD locations.

The successful candidate will bring experience inGMP Quality Controlgood documentation practices andright-first-time execution with a strong ability to work across analytical operational and cross-functional activities. Testing may includeimmunoassays chemical and physical analyses and cell-based assays.

Key Responsibilities

Method Development

• Executesmethod developmentactivities to supportraw material qualificationin preparation for commercial manufacturing.

Technical Transfer and Analytical Execution

• Supportsthetechnical transfer qualification and validationof QC methods for raw materials.

• Contributesto thedesign and execution of analytical studiesto assess thequalityofcelltherapycontrolledmaterials.

Quality Control Operations

• Perform routine raw material testing analysis and releasein accordance withcompendial methods such as USP and EP internal test methods standard operatingproceduresand specifications ensuringtimelyavailability of released materials to support manufacturing and compliance with regulatory and quality standards.

• Maintain theQC laboratory and equipmentin accordance withapproved procedures.

• Author revise and reviewGMP documentatione.g.SOPs reports etc.

• Drivecontinuous improvement initiativesto enhance the efficiency compliance and effectiveness of QC operations.

Education and Experience

• Abachelors or masters degree or equivalent inbiological sciences chemistry biochemistry or a related fieldis.

• 5 yearsof relevant experience 3 yearsof relevant experience

Required Skills

• Experience inmethod developmenttechnical transferqualification and/orvalidation

• Hands-on experience with analytical techniques suchaspHFTIR/RamanHPLCELISA andwet chemistry compendial methods

• Working knowledge ofcompendial requirements includingUSPandEP

• Experience in aQuality ControlorGMP testing laboratory with knowledge ofcGMPand regulatory requirements for raw materials

• Strongattention to detailproblem-solving anddocumentationskills

• Effectiveinterpersonalverbal andwritten communicationskills

• Ability to work collaboratively in ahigh-performing team environment

Preferred Skills

• Experience performing or managingraw material analytical testingwithshort turnaround times

• Experience withdigital laboratory systemssuch aselectronic notebooksLIMS andSAP