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Quality Assurance Associate

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Company :
Cambridge Isotope Laboratories, Inc.

Location :
Tewksbury, Massachusetts

Expiry Date :
Sun, 13 Jun 2021 23:59:59 GMT

Apply Job :
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Description :
Cambridge Isotope Laboratories has an outstanding opportunity to join our Quality Assurance team as an entry-level Quality Assurance Associate based onsite in our Tewksbury, 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 40 years.

This is a great opportunity to enter the Quality Assurance field and be part of a GMP/ISO environment responsible for the quality of several new and existing active pharmaceutical ingredients (APIs) and medical device components.

Responsibilities

* Maintenance and management of CILs change control process by helping with the initiation of change control, tracking of documents, and final distribution of the approved documents
* Perform room/line clearances, creation of logbooks and controlled forms and form reconciliations
* Review and release of raw materials
* Provide back-up coverage to the stability, training and calibration coordinator
* Support the performance of the other appropriate Quality Assurance functions including document writing/revisions, deviations, CAPAs, document/data review and other administrative duties as needed

Requirements

* BA/BS in Science or Quality preferred
* 0 to 2 years of experience within Quality Assurance
* Knowledge and/or experience in ISO 17025, ISO 13485, GMP and ICH Q7A a plus
* Detailed-oriented, possess excellent verbal and written communication skills, good interpersonal and organizational skills and be a team player
* Some travel between facilities is required as this position supports both Andover, MA and Tewksbury, MA locations

Benefits

CIL offers a competitive salary and a comprehensive benefit program including generous paid time off, health insurance with 100% company paid deductibles, Long Term Incentives and 6% matching 401K plan.

CIL is an EEO/Affirmative Action employer.

Learn more about us on our website: [

About us:

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