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ISO Quality Specialist

3 months ago

Andover, United States Cambridge Isotope Laboratories, Inc. Full time

Cambridge Isotope Laboratories, Inc. (CIL) is searching for an ISO Quality 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 ISO Quality Specialist will be responsible for development, implementation, and maintenance the organization’s Quality Management System for non-GMP products. This individual will be hands on, working with multiple departments, to ensure that all non-GMP processes conform to ISO 9001 standards. Required competencies include customer focus, chemical process manufacturing, working with cross-functional teams and leading change throughout the facility. The primary responsibility of the Quality Specialist is to maintain the adherence to quality standards for non-GMP products.

Responsibilities

  • Develop, implement, and maintain an ISO 9001: Current version quality management system/program for all non-GMP products that conforms to customer, internal, ISO 9001 and regulatory/legal requirements
  • Develop and perform relevant training in support of the Quality Management System
  • Lead and manage the customer complaints process including investigation and resolution
  • Lead ISO internal audits and related activities
  • Manage corrective action and preventive action (CAPA) program for non-GMP products
  • Act as company point of contact during customer inquiries, including customer audits and questionnaires
  • Monitor/measure processes for the detection of continuous improvement opportunities
  • Work with production and engineering to ensure processes meet quality expectations

Requirements

  • Bachelors Degree in a science concentration preferred
  • Minimum of 5 years of experience in an ISO 9001-accredited environment preferred
  • Experience working with CAPA and internal audits
  • Excellent interpersonal, verbal and written communication skills required
  • Attention to detail, strong organizational skills, ability to multitask

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