CIL Isotope Separations has an exciting opportunity to join our growing team as a Quality Administrator based onsite at our Xenia, OH location. As the leading company in a niche scientific market, CIL works with cutting edge researchers in clinical diagnostics, metabolic research, proteomics, environmental testing, protein discovery, drug development, metabolomics, and industrial research. 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 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 40 years.

The Quality Administrator will be responsible for supporting the Quality Management System (QMS) for non-GMP products. This individual will be hands on, working with multiple departments, to maintain control and retention of documentation associated with the QMS. Required competencies include detail oriented, organized, analytical, and problem-solving ability. The primary responsibility of the Quality Administrator is to support the processes and maintenance of the QMS for non-GMP products.

Responsibilities

• Serve as Administrator of the document control database
• Assist with document revisions and final distribution after approval
• Review completed documentation, such as forms, logbooks, and batch records
• Ensure that appropriate records are properly controlled and manage the storage/filing of controlled documents
• Participate in the quality management system, which may include supporting internal auditing, corrective actions, change control and nonconformances activities
• Initiate the periodic review process of site documents
• Support assignment of training curriculums for site personnel
• Provide back up support to the Training Coordinator for LMS
• Initiate supplier approvals
• Maintain metrics associated with the QMS
• Support continuous improvement project as assigned
• Perform other job-related duties as assigned by management

• A minimum of 5 years Quality department experience in an ISO 9001:2015 accredited environment preferred
• HS Diploma required
• Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word)
• Beginner to intermediate level experience with SharePoint preferred
• Strong organizational skills, time management, accuracy, and attention to detail required
• Excellent interpersonal, verbal, and written communication skills required
• Work independently and in a team environment
• GMP experience a plus

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

CIS is an EEO/Affirmative Action employer.

Learn more about us on our website:

About us:

Cambridge Isotope Laboratories, Inc. (CIL) is the world's leading producer of and stable isotope-labeled compounds. With nearly 600 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). CIL's 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: