Xenia, Ohio, United States
Quality Assurance Specialist
Cambridge Isotope Separations (CIS) has an opportunity for an experienced Quality Assurance Specialist in our Xenia, OH location.
CIS is a world leader in the separation of 13C and 18O and is a subsidiary of Cambridge Isotope Laboratories (CIL) in Massachusetts, the world’s leading producer of stable isotopes and stable isotope-labeled compounds. CIL separates both 13C and 18O at its Xenia, Ohio, facility and has the world’s largest production capacity for both 13C and 18O. CIL also has the only large capacity nongovernmental D2O (Deuterium Oxide) enrichment columns in the world located at its CIS facility.
CIL & CIS have had consistent growth and profitability for 35 years. Our growing customer base spans academia, pharmaceutical and industry, enabling collaborations with Nobel laureates, industry-leading scientists, and chemists. We partner with leading instrument manufacturers as well pioneering research groups that have expertise in product development and drive market growth.
Our employees are active contributors to the company’s success and enjoy long term careers. More than 95% of senior managers have been with the company for more than 15 years. Our employees appreciate the small company atmosphere, value of employee contributions, team camaraderie and excellent benefits package.
The responsibilities for this role include, but are not limited to, the following:
- Incumbent will work closely with the CIS Quality Assurance group for the maintenance and management of the Quality Management System (QMS)
- Responsible for performing batch record review, room/line clearances, report writing and auditing
- Responsible for the review and release of raw materials
- Assist in the performance of other appropriate Quality Assurance functions including document writing/revisions, deviations, CAPA’s, document/data review, continuous improvements and other administrative duties as needed
- Active participant in project meetings and internal audits at all CIL locations (Tewksbury /Andover, Massachusetts and Xenia, OH), as required
- Bachelor’s in Chemistry or related science discipline
- A minimum of 5 years of experience with Quality Assurance in a GMP setting
- Knowledge and/or experience in ICH Q7 is a plus
- The successful applicant will be detailed-oriented, possess excellent verbal and written communication skills, good interpersonal and organizational skills and be a team player
CIS offers a competitive salary and comprehensive benefits, including generous paid time off, health insurance, matching 401k plan and opportunities for career growth.
If you are a highly motivated professional who meets the qualifications for this position, please submit your resume.
CIS is an EEO/Affirmative Action employer.
Application Link: https://www.isotope.com/corporate-overview/Careers.cfm