Sr. Analyst, Supplier Quality - FWN
Provides primary leadership, quality assurance oversight, and scientific / technical direction for all supplier management activities.
Safety and Housekeeping – Adhere to safe work practices for supplier QA management.
- Follow safety standards in various areas worked
- Wear appropriate PPE
- Maintain clean and safe work environment
- Identify and report safety hazards
- Perform and document routine assessments of area to identify / confirm ongoing compliance to safety and housekeeping requirements.
Planning – Actively identify and coordinate supplier management activities to meet compliance and business needs.
- Assess work load and business demand/project timelines to prioritize supplier management activities (non-conformances, CAPAs, supplier reviews, quality agreements, etc.)
- Effectively plan and follow up with 3rd parties to obtain required documentation for approval and maintenance of supplier management programs.
- Plan and schedule supplier assessments to support the global audit plan for third party.
Technical – develop, implement, and assess supplier management requirements to maintain compliance of supplier management program.
- Perform non-conformance investigations and CAPA completions for supplier non-conformances.
- Perform and approve supplier review assessments to assure compliance with supplier requirements including verifications for TSE/BSE, audits, certifications, supplier agreements, and review of quality of receipts.
- Lead change control documentation for supplier notifications/process changes.
- Lead supplier change control documentation and maintain approved supplier lists.
- Populate and evaluate monthly supplier quality metrics for management oversight review.
- Create and maintain supplier quality agreements to assure component requirements are established.
- Perform component investigations and completion of technical reports for support of customer complaints.
- Generate and maintain incoming quality inspection plans.
- Write and complete qualification reports for packaging components to support reduced inspection testing.
- Write and assume ownership of SOPs/forms related to supplier management.
- Identify key process attributes and quality parameters for new materials.
- Evaluate and approve tooling construction authorizations and tooling qualification summaries to assure compliance to quality parameters.
- Assessment of base documents, test methodology, and sterilization processes to support incoming inspections.
- Review and approval of engineering specifications/drawings.
- Lead supplier development and improvement initiatives.
- Obtain and maintain Novartis Certified Auditor criteria.
- Plan, schedule, and conduct supplier audits.
- Complete audit reports and enter results / observations within computerized systems.
- On-going monitoring and follow up with suppliers for audit actions and CAPA requests.
Team – Support suppliers and coworkers to maintain supplier management program and incoming inspection requirements.
- Works closely with cross functional teams (QA, Pkg. Eng, Purchasing, QC labs, suppliers) to manage non-conformances, CAPAs, supplier reviews, change controls, and quality agreements.
- Contributes to departmental meetings; provide scientific and technical support for components.
- Provides guidance and expertise for components and internal policies and processes to assure regulatory compliance and quality systems are maintained.
- Lead teams for quality improvements, process monitoring, and tracking of supplier quality activities.
- Demonstrates flexibility in work hours
- Demonstrate Alcon Values & Behaviors
Interfaces – Coordinate with cross functional groups to complete projects.
- Communicate quality non-conformances to QC Incoming Inspections, Production, Planning, Pkg.Eng, QA , and other groups as needed to assure component availability and compliance to standards.
- Coordinate with suppliers and other affiliates to obtain supplier data and information to sustain supplier management program.
- Primary interface to QC Incoming Inspection for component standards and requirements and package engineering specifications.
- Primary contact for supplier component management activities.
- Interface with Health Authority agencies as needed. EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements Bachelor's degree or 10 equivalent years of directly related experience
Fluent in English
2 years of directly related experience
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