ISO Quality Assurance Specialist

Organization: 
Cayman Chemical
Job Location: 
Ann Arbor, Michigan
Salary: 
negotiable
Job Description: 

Cayman Chemical Company is a biomedical research company based in Ann Arbor, Michigan. Cayman helps make research possible by supplying scientists worldwide with biochemical tools used to understand cancer, neurochemistry, oxidative injury, endocrinology, atherosclerosis, and other human health challenges. We specialize in assay kits for the measurement of hormones and bio-markers. In addition, Cayman offers a broad range of specialty biochemicals used as research reagents and qualified standards. Cayman performs generic drug development and production in both Ann Arbor, Michigan and Neratovice, Czech Republic. The accountabilities for this position are:

•Develop policies and procedures in compliance with ISO requirements and industry standards.
•Implement and maintain Cayman ISO Quality Management System for Cayman’s ISO Reference Materials Division.
•Review manufacturing and analytical data and protocols associated with the validation, testing, and release of ISO Reference Materials.
•Maintain compliance to ISO Guide 17025 and ISO Guide 34. Write and maintain ISO SOP documents.
•Implement ISO improvement initiatives through corrective action planning and out of specification investigations.
•Participate in the management and control of suppliers and contractors, including the assessment and audit of suppliers.
•Participate in and lead quality investigations, ensuring that effective CAPA actions are implemented.
•Conduct internal audits and QA walkthroughs in order to verify compliance with ISO principles.
•Host external audits by customers and regulatory authorities.
•Develop and deliver training on Quality Systems/procedures to colleagues.
•Review and assess technical and/or quality agreements with customers and suppliers when required.
•Promote and maintain a high standard of customer care.
•Develop and maintain a quality culture of continuous improvement.

Requirements: 

•Master degree in Life Sciences or Chemistry with 2+ years relevant lab experience or Bachelor degree in Life Sciences or Chemistry with 5+ years relevant lab experience.
•5+ years experience in QA systems, particular experience with ISO Guide 34 and/or ISO Guide 17025 preferred.
•Proficient in Microsoft Office.
•Strong written and verbal communication skills.
•Excellent analytical and critical thinking skills.
•Proficient organizational skills including high attention to detail.
•Able to prioritize work and identify and resolve problems.

Cayman offers two different medical plans, dental, vision and medical/dependent care flexible spending accounts. Cayman is proud of our generous paid time off plan, 8 paid holidays per year and incredibly flexible work schedules. We also offer additional benefits including life and disability insurance, a 401k with company match, educational assistance and a variable compensation plan.

Cayman is an Equal Opportunity Employer and participates in E-Verify. You can take pride in being a member of the Cayman team and working in an environment where we truly care about our products, our research and each other.

Contact Information: 

Please apply online at www.caymanchem.com under the careers section.