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Quality Control Documentation Specialist

2 months ago

Tewksbury, United States Cambridge Isotope Laboratories, Inc. Full time
Job DescriptionJob Description

Cambridge Isotope Laboratories, Inc. (CIL) is searching for a Quality Control Documentation Specialist based onsite in our Andover, MA facility. CIL is 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.

The Quality Control 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 products undergeneral supervision and in accordance with standard operating procedures (SOPs). The QC Documentation Specialist maintains the Quality Control document system, paper and electronic, including but not limited to laboratory notebooks, logbooks, and controlled forms, and electronic data. They may also compile data and prepare reports for purpose of trending or support for investigative purpose.

Responsibilities

  • Review batch data for release of GMP/ISO and/or non-regulated materials by ensuring the product meets set standards
  • Review data, including raw data, laboratory notebooks, logbooks, and forms, for completeness and accuracy, including audit trails and electronic data
  • Train on and follow documented procedures under GMP guidelines
  • Compile data for trending purposes, i.e. cycle times
  • Author or edit test procedures and SOPs
  • Support investigation team by compiling or reviewing related data
  • Prepare summary or trend reports
  • Write deviation, CAPA reports, including root cause analysis and implementing appropriate corrective actions
  • Track and maintain laboratory notebooks, logbooks, controlled forms, spreadsheets, training records, and other QC related documents
  • Train others on practices of data review and documentation

Requirements

  • BS degree in Chemistry, or another relevant science concentration
  • 3 or more years of technical experience with GC, GC/MS, ICP-MS, LC/MS, NMR or HPLC experience required; QC and GMP experience preferred
  • Hands-on experience with ELN or LIMS software strongly preferred
  • Previous experience with review or peer assessment of analytical data
  • Must be able to multi-task, take initiative, and follow through in a fast-paced environment
  • Must be able to work efficiently and independently under general supervision
  • Must work well in a team-oriented environment and possess strong interpersonal skills including verbal and written communication
  • Have the ability to focus on streamlining workflows and providing solutions for continuous improvement
  • Must be able to travel between sites (Tewksbury, MA and Andover, MA)
  • Must be able to lift up to 50 lbs and utilize transport aids
  • Must be comfortable handling various chemicals and gases in a laboratory setting

Benefits

CIL and CIS offer a competitive salary and 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 approximately 750 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

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