The Supplier Quality Specialist will be responsible for all quality compliance activities relating to third party manufacturer/service providers and other suppliers. This role will manage qualifications and surveillance audits of suppliers as assigned, manage the lifecycle of supplier nonconformances and the Supplier Corrective Action 9SCAR) process, and collecting, assessing and reporting on supplier quality data.
- Interface directly with suppliers, third party logistics and CM’s to develop and implement product and/or process controls required so that supplied material meets all requirements.
- Full engagement and ownership in resolving all supplier quality issues per quality system requirements and use of the Supplier Corrective Action Process.
- Maintain suppliers’ compliance (updated certificates on file, perform suppliers’ re-evaluation)
- Activate and deactivation of suppliers as per procedure.
- Develop and sustain processes for incoming inspection requirements to be the logical result/outcome of pFMEA/Control Plan approach for controlling risk
- Ensure that process control tools like FMEA’s and Control Plans are living documents at our suppliers.
- Initiate supplier & quality agreements as per procedural requirements.
- Perform both Quality System and Product Quality supplier audits.
- Documents and follows up on audit results and required actions to be addressed by the supplier.
- Develop, assess & optimize supplier process as needed.
- Participate in Material Review Board (MRB) review of nonconforming product; recommend disposition and corrective action
- Track, analyze, and report on supplier performance metrics to stakeholders along with recommendations for tactical and strategic improvements
- Actively participate in the assessment and improvement of quality system processes with emphasis on supplier development/quality
- Other duties as assigned
- Bachelor’s Degree or higher preferred; ideally in a related scientific discipline
- 3-5 years’ experience in a quality role, ideally in an ISO 9001:2015 or pharmaceutical manufacturing environment.
- Working knowledge of cGMP and GDP preferred
- Trained/certified ISO 9001:2015 supplier quality auditing experience
- Strong verbal and written communication skills, including the ability to write technical reports / presentations and to negotiate Supplier Quality Agreements
- Solid organizational and follow-up skills, as well as attention to detail
- Critical thinker with analytical problem-solving skills, able to resolve quality-related issues in a timely and effective manner
- Awareness of various process-improvement methodologies, such as Six Sigma and Lean Manufacturing
- Project Management (conducting status meetings, project reporting, etc) is a plus.
- Knowledge of nonconformance, CAPA, and other standard compliance systems.
- Proficiency in Microsoft Office and job-related computer applications required
- Strong Collaboration Skills
- Ability to work as part of a cross functional team
- Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
- Demonstrated ability to drive the completion of tasks
- Proven decision-making capability with accountability and responsibility
- Work related travel required (up to 25%)