Cgmp Quality Assurance Specialist

Cambridge Isotope Laboratories, Inc. Xenia , OH 45385

Posted 6 days ago

Cambridge Isotope Separations (CIS) has an outstanding opportunity for an experienced cGMP Quality Assurance Specialist based onsite in our Xenia, OH location. 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 minimal supervision, utilizing in-depth knowledge and understanding of cGMP (current Good Manufacturing Practices), QA (Quality Assurance) and the companys production capabilities, the incumbent is responsible for the implementation, maintenance, and continuous improvement of CIS' Quality Management Systems.

Responsibilities
  • Responsible for batch record review.
  • Responsible for release of raw materials and finished products.
  • Primary coordinator of the CIS CAPA (Corrective Action and Preventative Action) program. This includes reviews of sufficient root cause analysis, review/approve CAPA and effectiveness plans, perform effectiveness check, etc.).
  • Assist and/or perform internal audits.
  • Assist with external audits, including supplier audits.
  • Perform related QA functions in support of ISO and the cGMP QMSs to include but not limited to: batch release and data review, document writing/revision, closing deviations, investigating OOS (Out of Specification) results, room clearances, non-conformance and training.
  • Perform equipment qualification protocol reviews and approvals.
  • Author annual product reviews (APRs) for APIs and related products.
  • Perform any related work as required.

Requirements

  • Bachelors Degree in chemistry or related field of study preferred; equivalent applicable industry experience may be substituted for the degree requirement.
  • Minimum 4-7 years of experience in a GMP setting.
  • 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. 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.

Benefits

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: www.isotope.com

About us:

Cambridge Isotope Laboratories, Inc. (CIL) is the worlds leading producer of stable isotopes 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). 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: www.isotope.com

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Cgmp Quality Assurance Specialist

Cambridge Isotope Laboratories, Inc.