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Cambridge Isotope Separations (CIS) is searching for a GMP Quality Assurance (QA) Associate located in Xenia, Ohio. Cambridge Isotope Laboratories (CIL) and CIS are the global leading company in a highly technical, extremely fast-growing industry and is a critical supplier to several scientific and high technology markets. CIL's growing customer base spans academia, pharmaceutical, medical diagnostic and semiconductor industries enabling collaborations with Nobel laureates, industry-leading scientists, and chemists. CIL partners with leading instrument manufacturers as well pioneering research groups that have expertise in product development and drive market growth. CIL is a subsidiary of the Otsuka Pharmaceutical Group and has had consistent growth for over 40 years.

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

Responsibilities

• Perform room/line clearances
• Revision and creation of documents, including SOPs 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

Requirements

• Bachelors 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

Benefits

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

CIL is an EEO/Affirmative Action employer.

Learn more about us on our website: (link removed)

About us:

Cambridge Isotope Laboratories, Inc. (CIL) is the worlds leading producer of stable isotopes and stable isotope-labeled compounds. With over 700 employees and laboratories in four countries, CIL specializes in the process of labeling biochemical and organic compounds with highly enriched, stable (nonradioactive) isotopes of carbon, hydrogen, nitrogen and oxygen. Our chemists substitute common atoms (e.g., 1H, 12C, 14N, 16O) with rare, highly valued isotopes (e.g., 2H or D, 13C, 15N, 18O) so that the final product can be readily measured or traced using mass spectrometry (MS) or nuclear magnetic resonance (NMR). CILs products are utilized in laboratories, medical, government and academic research centers and health care facilities worldwide.

We are proud that CIL products have contributed to medical advancements in cancer research, new-drug development, environmental analysis, and medical diagnostic research. In the past decade, as the fields of proteomics and metabolomics have developed as leading techniques for determining biomarkers for disease presence, progression and the monitoring of therapeutic response, CIL has worked closely with industry leaders and researchers to provide the stable isotope-labeled tools needed for improved quantitation and qualification of complex biological systems.

After decades of research, stable isotopes have found their place in an ever expanding commercial scale applications in pharmaceuticals, semiconductors, flat panel displays as well as other high technology fields specifically with deuterium oxide (D2O) and deuterium gases. Pharmaceutical companies have begun to investigate deuteration of molecules that may provide advantages over their existing nondeuterated counterparts. In addition, increasing research into the potential medical advantages of new deuterated drugs is also occurring. In high technology, deuterated organic molecules and deuterium gas are commonly used in the manufacturing of microelectronics and OLEDs, which contribute to the increased lifetime of the devices.

Learn more about us on our website: (link removed)