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Form of workJob Description
Cambridge Isotope Laboratories, Inc. (CIL) is seeking a Quality Control (QC) Documentation Specialist to join our team based onsite in our Andover, MA 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 over 40 years.
The QC Documentation Specialist is responsible for performing the data review for the release of regulated and/or non-regulated materials including raw materials, in-process and finished formulations under general supervision and in accordance with standard operating procedures (SOPs). The QC Documentation Specialist also compiles data for documentation of test procedures, performs investigations, and prepares reports.
Responsibilities
- Review data for release of GMP/ISO and/or non-regulated materials
- Follow documented procedures
- Document test data as required
- Write test procedures and SOPs as required
- Perform investigations as required
- Prepare reports as required
Requirements
- BS degree in Chemistry, Chemistry Informatics or other relevant science degree
- 3 or more years of relevant industry experience (GC,GC/MS, NMR or HPLC experience a plus)
- GMP and/or ISO experience preferred
- Hands-on experience with Biovia LES/LIMS system strongly preferred
- Must be able to handle multiple tasks, take initiative, follow through
- Must possess strong verbal and written communication skills
- Must be able to work effectively independently and as part of a team
Benefits
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: www.isotope.com
About us:
Cambridge Isotope Laboratories, Inc. (CIL) is the world’s 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). 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: www.isotope.com
