Specialist Quality Control

Facility

Role overview

Change control and verification

• Own 1Lab change controls from initiation through implementation and closure, including impact assessments, action tracking, evidence, effectiveness checks, and approvals.
• Coordinate assessments of GMP, data-integrity, process, documentation, validation, equipment, material, and system-interface impacts.
• Plan, execute, and document verification of 1Lab activities, recipes, workflows, equipment events, and interfaces using approved procedures and representative scenarios.
• Review verification evidence for accuracy, completeness, traceability, and procedural alignment; coordinate discrepancy resolution and retesting.

Documents and readiness

• Assess impacted SOPs, work instructions, forms, logbooks, guides, and training materials; draft and route revisions for future-state workflows and retained controls.
• Keep terminology, calculations, result reporting, acceptance criteria, roles, and instructions consistent across 1Lab and supporting records.
• Develop go-live criteria and confirm prerequisite change actions, system activities, master data, documents, training, and access are ready.
• Provide training, coaching, office-hour support, and job aids to analysts, reviewers, super users, and stakeholders.

Coordination and records

• Facilitate document and change reviews, working sessions, risk discussions, and readiness meetings; communicate decisions, dependencies, risks, and due dates.
• Maintain inspection-ready records in document, training, change-control, and project repositories according to cGMP, documentation, and data-integrity expectations.
• Perform assigned duties related to QC digital implementation, laboratory systems, and continuous improvement.

Qualifications

• Bachelor'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.
• The source also begins a qualification concerning independent management, but the description is truncated before the full requirement.