QA Specialist IV, Supplier Quality - United States
The Supplier Quality QA Specialist IV is responsible for managing compliance and supporting continuous improvement activities associated with quality systems, site goals / objectives and inspection readiness for all tasks related to Supply Chain Quality and Supplier Quality Management. The QA Specialist IV is responsible for ensuring compliance for all raw material related issues and Good Manufacturing Practices for Alexion products. This position is empowered to be the Quality Assurance Signatory on all Quality System Documents originating from external suppliers. This position will organize departmental or cross-functional teams and activities to ensure completion of projects while adhering to budget, scope and schedule requirements. This position may lead investigations, resolve potential quality issues, recommend and implement changes as necessary and network globally across Alexion sites. The Supplier Quality QA Specialist IV will interact with suppliers and distributers to maintain strategic relationships and ensure current Quality Agreements, Supplier Change Notifications, and manage Supplier Complaints and Investigations as well as Supplier CAPA.
- Performs all responsibilities in accordance with company policies, procedures, federal regulations, and safety requirement
- Support QC -Raw Materials department in raw material specification review, disposition and release.
- Quality Agreements generation and maintenance.
- Manage Supplier Quality programs such as Vendor Management, Supplier Change Notifications, Approved Vendor List, Supplier Event Notifications and Investigations, Damaged and Defective Raw Materials, and Extraneous Matter Events.
- Makes recommendation to Director, Quality Assurance Operations for the release of product based on impact associated with Raw Material related issues.
- Works closely with Manufacturing, Facilities, Logistics, Technical Manufacturing Services and Quality Control to resolve open issues resulting from damaged and defective raw materials and extraneous matter.
- Reviews and assesses deviations; including performing risk assessments, participating in root-cause analysis investigations, tracking, follow-up, and reporting/trending.
- Reviews and approves Corrective and Preventative Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.
- Interacts professionally with suppliers, company management, internal departments and other sites globally to effectively implement and maintain Quality Systems.
- Representing Quality Assurance at various project and technical meetings, as needed.
- Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending.
- Provide reports, data analysis and ensures flow of communication between technical groups and external suppliers/customers including following up on and resolving issues that arise. Report on metrics and supplier quality performance.
- Minimum of 8-12 years GMP related experience in biopharmaceutical / pharmaceutical or related industry with 3-5 years direct QA/QC experience preferred. Previous experience with Raw Materials and Quality Control preferred.
- BS/BA degree in Life Sciences or related field
Smithfield, RI, United States
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Alexion is an Equal Opportunity /Affirmative action employer