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.

We are currently seeking applications to fill the following job opening at Asahi Kasei Bioprocess where we sell Planova® virus removal filters and develops and manufactures related bioprocess equipment.

Company:

Asahi Kasei Bioprocess America, Inc.

Job Description:

We are seeking a Supplier Quality Engineer I to lead supplier qualification activities including managing AKBA’s supplier audit program and supplier management systems. You will be building and improving our relationships with and the performance of our suppliers, establishing and maintaining AKBA’s approved supplier list and supplier quality agreements, and partnering with Purchasing to support supplier selection and sourcing decisions. If you are seeking an energetic and helpful team environment, enjoy creating and making an impact, please apply.

As an Asahi Kasei Bioprocess America employee, you will enjoy:

• Strong company culture
• Competitive Compensation with Bonuses
• Great health benefits with the company paying over 80% of insurance premiums
• Wellness Program
• Paid Time Off
• Strong company match to 401(k) contributions
• Tuition reimbursement program
• Giving Program
• Paid Parental Leave

ESSENTIAL DUTIES/RESPONSIBILITIES

• Manage Fluid Management Division suppliers by:

• Owning the supplier management process with responsibility over process metrics and improvements
• Negotiating and establishing quality agreements with suppliers to ensure clarity of AKBA expectations and product/service specifications, and ensuring consistency with accompanying sales and other supply agreements
• Managing the activities of the Supplier Task Force to facilitate new supplier searches and trials, driving completion of these initiatives and onboarding chosen suppliers
• Leading supplier audits (planning, facilitating, and reporting), and working together with suppliers to achieve satisfactory corrective action response and improved quality and delivery performance
• Monitoring and analyzing supplier performance data (including nonconformances, on-time delivery, responsiveness, etc.) to identify severe or repeated supplier quality issues and trends, and driving improvement by providing performance feedback to suppliers via corrective action requests, data-driven scorecards, and targeted improvement meetings
• Managing supplier changes by monitoring and analyzing incoming supplier change notifications, working with AKBA stakeholders to determine impact on AKBA and our product lines, and liaising with suppliers to clarify and take action as needed
• Owning the Supplier Management module in EtQ Reliance, including managing supplier qualification requests, supplier reviews, and other supplier-related tasks

• Perform internal quality system audits, as required

• Facilitate and record Corrective and Preventive Action (CAPA) root cause analyses (RCA) and action plans and perform CAPA effectiveness checks

• Other quality-related tasks, as required

ADDITIONAL DUTIES/RESPONSIBILITIES

• Special projects, as assigned
• This role’s participation in supplier trials, supplier audits, and other internal and external meetings requires domestic and international travel

MINIMUM REQUIREMENTS

• Bachelor's degree in Engineering, Quality, Manufacturing, or a related technical discipline
• At least 3 years of work experience in Engineering, Quality Engineering, Supplier Quality, or Manufacturing Quality
• Working knowledge of ISO 9001 standards, as well as quality tools, terminology, and concepts
• Experience with supplier auditing, risk-based supplier management, and quality metrics
• Excellent written and verbal communication skills
• Intermediate to advanced knowledge of Microsoft Office programs
• Expertise in data analysis and trends analysis
• Strong critical thinking, analytical, and decision-making skills to solve problems associated with the determination of root causes
• High attention to detail, high quality work
• Strong facilitation, relationship-building, and influencing skills
• Self-starter, highly motivated to learn

PREFERRED SKILLS

• Experience in bioprocessing, life sciences, medical devices, or regulated manufacturing environments
• American Society for Quality (ASQ) Certified Quality Auditor (CQA) or similar certification
• American Society for Quality (ASQ) Certified Supplier Quality Professional (CSQP) or similar certification
• Experience with QMS management software (such as ETQ Reliance)
• Experience with ERP software (such as Microsoft Business Central (BC))
• Agreement & specification writing experience
• Microsoft PowerBI

Physical Demands/Environmental Conditions

• Position has the capability of hybrid work-from-home / in-office
• Travel up to 30%, domestic and international

The base compensation range for this role is $90,000-$95,000. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.

Please note, we will not be providing immigration-related sponsorship now or in the future for this role.

The Asahi Kasei Bioprocess (AKB) provides pharmaceutical and biopharmaceutical manufacturers with a comprehensive suite of tools to maximize safety and improve yields of biotherapeutics during research, clinical and commercial-scale production. Planova ™ virus-removal filters anchor a diverse product portfolio defined by quality, consistency and scalability. Additional areas of expertise include liquid chromatography, inline buffer dilution and oligonucleotide synthesis.

We are a growing team (145+) of professionals excited about what we do and our ability to impact healthcare delivery systems worldwide. We offer a "big company" benefits package and a "small company" culture and work environment. Every employee at Asahi Kasei Bioprocess America can impact our future.

#LI-MG1

#Hybrid

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.