Specialist Quality Control

Specialist Quality ControlOur Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world and has been recognized by our local community as being a Top 50' Business in Frederick and awarded Frederick County's 'Best Place to Work'. This distinctive biologic manufacturing facility, with over 800 employees, plays a direct role in treating patients with cancer, respiratory diseases, and autoimmune conditions globally.At FMC, we are committed to delivering life-changing medicines while also creating a workplace where people feel valued and connected. From catered site events and friendly competitions to community outreach, environmental and wellness programs, and team-building activities, we make time to celebrate achievements and recognize the diversity of our workforce. We are dedicated to fostering a culture of inclusion, collaboration, and continuous learning through ongoing skill development and training opportunities for our employees.Driven by our ambition to accelerate growth, improve patients' lives, and shape the future of AstraZeneca Operations, there has never been a more exciting time to join our team.The Specialist Quality Control will provide dedicated support for implementation of the Laboratory Execution System (LES), 1Lab, at the Frederick Manufacturing Center (FMC). This role will coordinate and execute quality-system activities required to transition laboratory processes from current-state workflows to compliant electronic execution, with primary accountability for change control ownership, activity verification, controlled-document revision, training readiness, and implementation review.Job ResponsibilitiesOwn and manage FMC 1Lab change controls from initiation through implementation and closure, including current-state and future-state descriptions, impact assessments, implementation plans, action tracking, evidence collection, effectiveness checks, and timely progression through required approvals.Coordinate cross-functional assessments with QC laboratory subject-matter experts, Quality Assurance, Quality Systems, training, information-system support, and global 1Lab project partners to identify GMP, data-integrity, process, documentation, validation, equipment, material, and system-interface impacts.Plan, execute, and document verification of 1Lab parent and child activities, recipes, workflows, equipment events, and interfaces using approved procedures and representative test scenarios.Review verification evidence for accuracy, completeness, traceability, and alignment with approved laboratory procedures; document discrepancies and coordinate resolution, retesting, or escalation before release to production.Assess impacted SOPs, work instructions, forms, logbooks, guides, and training materials; draft and route revisions that accurately describe future-state 1Lab workflows, review requirements, business-continuity processes, and retained paper controls.Ensure terminology, calculations, result reporting, acceptance criteria, roles, and procedural instructions remain consistent across 1Lab activities, source SOPs, laboratory systems, and supporting records.Develop implementation-readiness and go-live criteria, confirm completion of prerequisite change actions, and maintain objective evidence that system activities, master data, documents, training, and access are ready for use.Provide training, coaching, office-hour support, and job aids for analysts, reviewers, super users, and other stakeholders on applicable 1Lab processes and revised procedures.Facilitate document and change reviews, working sessions, risk discussions, and readiness meetings; communicate decisions, dependencies, risks, due dates, and escalations to stakeholders.Maintain inspection-ready records in applicable document, training, change-control, and project repositories in accordance with current Good Manufacturing Practice (cGMP), good documentation practices, and data-integrity expectations.Perform other duties related to QC digital implementation, laboratory systems, and continuous improvement as assigned.Minimum QualificationsBachelor's degree in a scientific, engineering, information-systems, or related discipline, or an equivalent combination of education and relevant experience.Experience in a regulated pharmaceutical, biotechnology, or laboratory environment, with working knowledge of cGMP, good documentation practices, data integrity, and controlled quality systems.Demonstrated ability to author, revise, or review change controls, SOPs, protocols, reports, work instructions, training materials, or other controlled records.Strong technical writing, organization, problem-solving, and cross-functional communication skills.Ability to independently manage multiple deliverables, priorities, dependencies, and timelines while maintaining accurate, inspection-ready documentation.Preferred QualificationsExperience supporting implementation, validation, verification, or lifecycle management of a laboratory execution system, LIMS, chromatography data system, electronic document system, or other GxP computerized system.Experience with 1Lab/BIOVIA, Veeva Vault, Empower, GQCLIMS, CISPro, SAP, or comparable laboratory and quality systems.Experience owning complex change controls and coordinating implementation across multiple QC laboratories or functions.Knowledge of risk assessment, computer-system validation, electronic records and signatures, review by exception, system interfaces, and laboratory business-continuity practices.Experience developing or delivering role-based training and supporting go-live or hypercare activities.