Cambridge Isotope Separations LLC (CIS) is seeking an experienced Quality Assurance Supervisor to oversee a growing quality assurance team based in our Xenia, OH location. Utilizing knowledge and understanding of GMP (Good Manufacturing Practices) regulations, quality assurance, and the company's GMP production capabilities, this position will oversee the compliance and documentation requirements for current and future GMP products. This position will also interface with the GMP Production Group, Quality Control, Operations and Logistics Departments and external stakeholders as needed to ensure compliance and maintenance of the company's Quality System.

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.

• Supervise the day-to-day operations of the GMP QA department
• Develop and monitor GMP compliant quality systems
• Supervise GMP QA staff members
• Serve as QA Manager designee in his/her absence
• Assist in investigation of out of specification (OOS) results, deviations and nonconformance
• Approve CAPAs (Corrective and Preventive Action documents) and deviation investigations
• Conduct internal compliance audits. Make procedural recommendations to ensure compliance
• Participate in and/or conduct external GMP compliance audits (e.g. suppliers, contract labs)
• Function as a liaison and a quality subject matter expert with notified bodies and external regulatory agencies such as the FDA
• Compose, review, revise and approve GMP related documents to include, but not limited to: SOPs (Standard Operating Procedures), protocols, validations, deviations, and system documentation
• Function as Project Manager for various GMP products. This may include the development and oversight of production plans, resource allocation and generation of timelines. Monitor project progress, ensure timely completion
• Support site Data Integrity programs
• Author annual product reviews (APRs) for APIs and related products
• Provide quality guidance and consultation to direct reports and management personnel to ensure that the company is GMP compliant
• Create and execute skill development plans for QA staff members
• Supports development of ISO9001 for non-GMP products
• Perform product release and Certificate of Analysis (COA) review
• Develop and conduct internal GMP training
• Performs data analysis to identify continuous improvement opportunities
• Perform any related work as required

• Bachelor's Degree in Chemistry or related field of study preferred; equivalent applicable industry experience may be substituted for the degree requirement
• Minimum of 8 years of experience with quality systems, GMP regulatory compliance, methods, and procedures preferably in a pharmaceutical environment
• Minimum of 3 years supervising or managing others is required
• Knowledge and/or experience with ISO 9001, 21 CFR 212 and/or ICH Q7 is preferred
• Excellent interpersonal, verbal, and written communication skills are required
• Attention to detail, organizational skills, ability to multitask and follow tasks through to completion
• Ability to work independently and in a team environment
• Work is performed primarily in an administrative office environment; however, some work is performed in an industrial plant environment

CIL 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.

CIL is an EEO/Affirmative Action employer.

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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.

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