Cambridge Isotope Separations (CIS) is searching for a GMP Quality Assurance (QA) Associate located in Xenia, Ohio. CIS is the world leader in the separation of stable isotopes and related chemistry. CIS and its parent, Cambridge Isotope Laboratories (CIL) in Massachusetts, are subsidiaries of the Otsuka Pharmaceutical Group. CIL separates both 13C and 18O at its Xenia, Ohio, facility and operates the only large capacity nongovernmental Deuterium Oxide enrichment columns in the world. We globally support a broad range of customers across many high-tech industries including pharmaceutical, semiconductor, medical diagnostic, display, and basic research. We are rapidly expanding, and the Ohio facility is an integral part of our growth for the future.

Under general supervision, the primary responsibility of the QA Associate is to work as a team member to ensure and maintain the Company's cGMP (Current Good Manufacturing Practices) compliance.

Responsibilities

• Perform room/line clearances
• Revision and creation of documents, including SOP's and forms
• Issuance, review, and tracking of training forms
• Create/Verify batch records and labels
• Issue/Review/Reconcile logbooks and controlled forms
• Assist with the initiation, tracking and final distribution of approved documents
• Perform any related work as required, based upon experience and training, such as:
  • Approved Supplier/Service Provider reviews
  • Weekly water and monthly pest control reviews
  • Review of manufacturing facility temperature and humidity data
  • Equipment calibration and qualification form maintenance and tracking

• Bachelor's Degree in chemistry or related science preferred
• Minimum of 0-2 years of experience in a GMP/ISO setting
• Excellent interpersonal, verbal and written communication skills are required
• Attention to detail, organizational skills, ability to multitask and follow tasks through to completion
• Work independently and in a team environment
• Work is performed primarily in an administrative office environment

CIL offers a competitive salary and a comprehensive benefits including generous paid time off, Long Term Incentives, 6% matching 401K plan and health insurance with no in-network deductible.

CIL is an EEO/Affirmative Action employer.

Learn more about us on our website:

About us:

As the leading company in a rapidly expanding increasingly critical scientific market, CIL and our subsidiaries supply over 15,000 products to 30,000 research customers around the world and work with cutting edge researchers in clinical diagnostics, metabolic research, proteomics, environmental testing, protein discovery, nuclear medicine, drug development, metabolomics, semiconductor, OLED and industrial applications. CIL has had consistent growth and profitability for over 40 years. CIL's growing customer base spans academia, pharmaceutical and industry, enabling collaborations with Nobel laureates, industry-leading scientists, and chemists. CIL partners with leading instrument manufacturers as well as pioneering research groups that have expertise in product development to drive market growth.

Cambridge Isotope Laboratories, Inc., with headquarters in Tewksbury, MA, is the world's premier producer of stable isotope labeled compounds and a world leader in the field of stable isotope separations. CIL has over 675 employees with laboratories in the U.S., Canada, France and Germany. CIL is a subsidiary of the Otsuka Pharmaceutical Group.

For over 40 years, CIL has specialized in the development, production, and marketing of stable isotopes and chemical compounds labeled with stable isotopes. Join us for excellent career opportunities as we drive the expansion of market applications with innovative product development.

Learn more about us on our website: