Specialist, Quality Operations
Asahi Kasei

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:

This position contributes to the Company's success by supporting the cGMP quality systems and quality event resolution to monitor the quality of third-party Contract Manufacturing Organizations (CMOs) throughout the entire product lifecycle.

Summary of Key Responsibilities

• Provides support of Veloxis Quality Systems (change control, document management, training) ensuring compliance and procedural controls as required.
• Maintains all controlled documents (electronic and hard copies) in accordance with internal Veloxis SOPs, FDA rules and regulations, Quality Agreements, and licensing partner expectations.
• Routes, tracks, reviews, edits, formats, updates, and uploads newly created or revised documents in accordance with internal Veloxis SOPs, facilitates periodic review.
• Supports electronic management system (eQMS) usage.
• Dispositions batch records and resolves issue related to strategic initiatives and compliance-related issues.
• Provides quality operations support for internal, vendors, and licensing partners including deviation review, change control action finalization and CAPA identification.
• Records relevant batch related data to support trending and continuous improvement.
• Communicates cross-functionally and collaborates to resolve quality systems gaps.
• Participates in small groups to investigate, recommend improvements, and support quality systems effectiveness.
• Develops quizzes in support of company training matrix to ensure SOP comprehension.
• Administers internal and external audit schedules, maintains supplier files.
• Archives quality documents in compliance with the Company's records retention policy and maintains archive storage area.
• Publishes KPIs for document control, change control, periodic review, and employee training. Contributes to monthly management report as it relates to assigned functions.
• Supports regulatory authority and licensing partner inspections, as needed.
• Performs additional assignments as directed by manager.

Required Qualifications and Skills

• BA / BS, preferably in scientific/technical discipline with 3-5 years of relevant industry experience or
  MS / MBA with 1-3 years' experience in a pharmaceutical manufacturing environment.
• Proven experience in supporting quality operations and/or systems within a pharmaceutical environment.
• Capable of supporting multiple projects simultaneously in a deadline-driven environment.
• Good communication skills; capable of making decisions with supervision, problem-solving, collaborate with other team members in a positive manner, and working in a support role within job function.
• Excellent organizational skills and ability to work on multiple projects with competitive timelines are required.
• Strong attention to detail.
• Some knowledge of FDA regulations
• Demonstrated ability to work effectively in cross functional team environment.
• Strong proficiency with Microsoft Office Suite required.
• Veeva Vault experience preferred.

Travel Requirements: < 5%, including travel outside of US

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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.

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