Specialist Quality Control

AstraZeneca's Frederick Manufacturing Center seeks a Specialist Quality Control to lead implementation of a Laboratory Execution System (1Lab). The role manages change controls, coordinates cross-functional assessments, and ensures compliant transition of laboratory processes with accountability for documentation, training, and go-live readiness.

Responsibilities

• Own and manage 1Lab change controls from initiation through implementation and closure
• Coordinate cross-functional assessments with QC experts and global project partners on GMP and data-integrity impacts
• Plan, execute, and document verification of 1Lab activities, recipes, workflows, and system interfaces
• Review and revise impacted SOPs, work instructions, and training materials to reflect future-state workflows
• Develop implementation-readiness criteria and maintain objective evidence of system and training completion

Requirements

• Bachelor's degree in scientific, engineering, information systems, or related discipline
• Experience in regulated pharmaceutical, biotechnology, or laboratory environment with cGMP knowledge
• Demonstrated ability to author, revise, or review change controls and controlled records
• Strong technical writing, organization, and cross-functional communication skills
• Ability to independently manage multiple deliverables, priorities, and timelines
• Experience with laboratory execution systems, LIMS, or GxP computerized systems (preferred)
• Knowledge of computer-system validation and electronic records practices (preferred)

Compensation: $55,920 - $83,881 annual base pay