Senior Quality Systems Specialist - Change Control

Overview Job Summary The Senior Quality Systems Specialist - Change Control serves as the site subject-matter expert and process lead for Change Control Management within Quality Systems & Compliance. The role governs changes across the Norcross Quality Management System, including product, process, equipment, software/system, facility, supplier, document, and labeling changes, to ensure changes are appropriately defined, risk-assessed, reviewed, approved, implemented, and verified before closure. The Senior Specialist facilitates cross-functional change assessments, ensures regulatory and quality impacts are identified early, maintains change-control metrics and inspection readiness, and drives consistent, right-first-time execution of the change process. Responsibilities Key Accountabilities Serve as the site Quality Systems subject-matter expert and process lead for Change Control Manage-ment, providing day-to-day governance of changes across product, process, equipment, soft-ware/system, facility, supplier, document, and labeling activities. Ensure change-control records clearly define the change, rationale, scope, risk, implementation plan, affected products/processes/documents, required approvals, and appropriate effectiveness or post-implementation verification. Facilitate cross-functional impact assessments to identify Quality, Regulatory, validation, design-control, risk-management, supplier, manufacturing, laboratory, training, documentation, and busi-ness-system impacts before approval and implementation. Ensure labeling changes receive appropriate Quality and Regulatory assessment, including affected labeling/technical documentation, implementation controls, inventory/disposition considerations, and required regulatory actions or approvals. Review change-control records for completeness, consistency, traceability, and compliance; challenge incomplete or inadequately assessed changes and provide clear guidance to change owners and re-viewers. Monitor change-control performance, including aging, due dates, implementation status, overdue actions, right-first-time quality, and recurring deficiencies; elevate risk and recommend improvement actions when needed. Maintain change-control standard work, guidance, templates, training materials, and process expecta-tions to promote consistent, compliant, and right-first-time execution across the site. Partner with Regulatory Affairs, Design & Sustaining Quality Engineering, Manufacturing QA, Labora-tory Services, Supplier Quality, Manufacturing, Engineering, Validation, Supply Chain, and other pro-cess owners to ensure impacts and implementation readiness are appropriately controlled. Support internal audits, regulatory/notified-body inspections, customer audits, Quality System met-rics, and QSMR reporting as the Change Control subject-matter expert, including retrieval and explana-tion of change records and performance data. Provide coaching and technical guidance to change owners and reviewers, identify systemic weak-nesses, and support process improvements, training, or CAPA while maintaining independent Quality System governance and appropriate escalation. Performs other duties and responsibilities as assigned Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Networking/Key relationships Network with Quality Systems & Compliance, Regulatory Affairs, Design & Sustaining Quality Engineering, Manufacturing Quality Assurance, Laboratory Services, Supplier Quality, Manufacturing, Engineering, Validation, Supply Chain, Information Technology/business systems, and other applicable organizations to ensure effective change assessment and controlled implementation. Qualifications Minimum Knowledge & Experience required for the position: Bachelor’s degree (BS/BA) from four-year college or university; or equivalent combination of education and experience. Four-year scientific/technical degree or 5 plus years of experience in a comparable manufacturing environment is required to ensure sound judgment and performance, preferred Experience/certification as a medical technologist is preferred Skills & Capabilities: Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, and government regulations. Ability to write reports, business correspondences and procedures manuals. Travel requirements: If required, provide approximate percentage of travelling time. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact View email address on click.appcast.io for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. #J-18808-Ljbffr UNAVAILABLE