The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.
Veloxis Pharmaceuticals is an Asahi-Kasei Group Company based in Cary, NC. Our purpose is to transform transplant medicine as the primary partner to the community of transplant healthcare providers and their patients; our focus is in developing new therapies and programs to help transplant healthcare providers and the patients they treat. Veloxis provides a dynamic and innovative place to work that encourages professional development and embraces diversity. We seek creative, intelligent, action-oriented, and passionate individuals who thrive in a collaborative team environment. If you are interested in being part of a patient-centric company, then we invite you to learn more about the employment opportunities available at Veloxis. Our success is tied to the contribution of every team member, which is why we provide a valuable and competitive compensation package that includes health and insurance benefits, training, and development opportunities, as well as performance-based bonus eligibility.
Company:
Veloxis Pharmaceuticals, Inc.
Job Description:
Summary of Key Responsibilities
- Assists in setting up continuous process validation (CPV) for an existing commercial product. This involves reviewing all batch records and pulling out the critical process data.
- Provides quality operations support for internal, vendors, and licensing partners including deviation review, change control action finalization and CAPA identification.
- Population of manufacturing and quality control related spreadsheets with current data.
- Archives Quality documents in compliance with the Company’s records retention policy and assists in maintaining archive storage area.
- Works directly with the Company’s Quality Assurance team to set up regulatory inspection dossiers and prepare PowerPoint documents that contextualize the layers of control. This involves organizing all technical reports and documents into an electronic folder and adding flow charts and support documentation to help regulatory inspectors understand the Company’s controls systems.
- Assists in developing quizzes and other training materials in Veeva Vault Training electronic system.
- Assists in setting up metrics in the Company’s continuous improvement plan.
- Other duties, as assigned.
Required Qualifications and Skills
- Major in Engineering, Chemistry, or a Life Sciences related field at an accredited university.
- Demonstrated attention to detail.
- Excellent interpersonal (both written and oral) skills, with the ability to successfully interact with scientific and non-scientific personnel.
- Ability to work in a dynamic, fast-paced environment with shifting priorities. Flexibility to adapt to changing priorities and manage activities to meet the needs of the business in a compliant manner.
- Willingness to “roll up his/her sleeves” to get the job done.
- Proficiency in MS Office Suite (Word, Excel, PowerPoint, Outlook), Adobe Pro.
As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.