Quality Control Analyst I

4 weeks ago

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

Cambridge Isotope Laboratories, Inc. has an outstanding opportunity to join our GMP Quality Control team as a Quality Control Analyst I based onsite in our Tewksbury, MA headquarters. 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 Analyst I is responsible for conducting routine analysis of GMP/ISO materials including: Raw materials, in-process and finished products under general supervision and in accordance with standard operating procedures (SOPs). The analyst will compile data for documentation of test procedures and prepare reports. They also calibrate and maintain lab equipment and participate in general upkeep of the laboratory.

Responsibilities

  • Responsible for conducting analytical testing for raw materials, finished product, and stability samples under GMP/ISO procedures and GLP practices
  • Train on and follow documented procedures and document test data in accordance with GMP guidelines
  • Responsible for performing maintenance, calibrations, and qualifications on equipment and instruments.
  • Be familiar with and utilize the following techniques to characterize organic and inorganic chemicals: NMR, GC/MS, GC, LC/MS, ICP-MS, HPLC, FT-IR and wet chemistry tests
  • Basic troubleshooting under supervision
  • Support Analytical chemists with investigative work and execution of methods during development stages.
  • Training other analysts in your area of expertise.
  • Author or edit procedures as required
  • Write summary reports for executed protocols, such as instrument qualifications
  • Write deviation, CAPA reports, including root cause analysis and implementing appropriate corrective actions.
  • Any additional functions as assigned, including but not limited to sampling, glassware cleaning, ordering and stocking of supplies, and general upkeep of the laboratory

Requirements

  • BS or MS degree in Chemistry or other relevant science degree
  • One or more years of technical experience with GC, GC/MS, ICP-MS, NMR or HPLC in industry required
  • QC and GMP experience required
  • Experience with ELN or LIMS software a plus
  • 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
  • Can focus on streamlining workflows and providing solutions for continuous improvement
  • Must be able to travel between sites to transport samples (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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