Supplier Quality Engineer I
Asahi Kasei Bioprocess America, Inc.Highlight
Summary
About the Role
About You
- 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 and quality tools.
- Experience with supplier auditing and risk-based supplier management.
- Excellent written and verbal communication skills.
- Intermediate to advanced knowledge of Microsoft Office programs.
- Expertise in data analysis and trends analysis.
- Strong critical thinking and decision-making skills.
- High attention to detail and quality work.
- Strong facilitation and relationship-building skills.
- Self-starter and highly motivated to learn.
- 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.
Benefits
- 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.
As a global partner to the biopharmaceutical industry, Asahi Kasei Bioprocess helps biologics manufacturers safely and efficiently produce medicines that patients can trust, by dependably supplying innovative yet exceptionally reliable bioprocess consumables, equipment and scientific support services. Our portfolio is anchored by Planova™ virus removal filters. First released in 1989 as the world's first hollow fiber filter developed specifically for removing viruses from biotherapeutic drug products, Planova™ filters ensure viral safety of biopharmaceutical drug products, thanks to their high quality and consistent performance. Leveraging 30 years of experience, we continue to provide our customers with products, services and expertise to achieve assurance that is beyond expectation. As part of our dedication to solving therapeutic product safety, efficiency and purity challenges, we also manufacture a comprehensive suite of downstream equipment. With technology platforms for virus filtration, chromatography, inline buffer formulation and oligonucleotide synthesis, our bioprocessing systems, columns and automation solutions advance GMP manufacturing of critical drug substances around the world. Our portfolio of market-driven equipment and cutting-edge technology touches unit operations across a wide range of therapeutic modalities, including classical small molecule pharmaceuticals, current-generation antibodies, plasma derivatives and next-generation oligonucleotide therapeutics.