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Cambridge Isotope Laboratories, Inc. Facilities Coordinator in Tewksbury, Massachusetts

Cambridge Isotope Laboratories, Inc. (CIL) is searching for a Facilities Coordinator based onsite in our Andover, MA location. 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.

Utilizing knowledge and understanding of cGMP (Current Good Manufacturing Practices), ISO standards, and the company’s Quality Management System, the Facilities Coordinator will interface with multiple departments at multiple locations (Production Group, Quality Control, Quality Assurance, Research Products, Operations and Logistics) to ensure compliance with the company’s Quality Management System, cGMP, and ISO standards. This individual will be detail-oriented with strong organization, communication, and time management skills, and should have the ability to work in a team environment and independently. This individual will also have the ability to excel in a fast-paced and fluid environment. Work is performed in an administrative office as well as a laboratory environment.

Responsibilities

  • Oversee, document, and lead all appropriate equipment calibrations/qualifications

  • Oversee, document, and coordinate equipment maintenance program

  • Coordinate equipment maintenance and calibration

  • Coordinate investigations into calibration/certification failures

  • Review operating reports, service reports, and inspection records to identify faulty equipment

  • Coordinate and manage daily workload

  • Escort vendors in critical areas

  • Write, review, revise and approve maintenance related documents to include, but are not limited to: SOPs (Standard Operating Procedures), protocols, validations, deviations, and system documentation

  • Act as back-up for the GMP calibration and qualification programs

  • Act as back-up for the GMP equipment documentation system

  • Maintain a problem-solving, service-first attitude for all interactions with both internal and external stakeholders

Requirements

  • Minimum of 2 years of experience with quality systems, GMP regulatory compliance, methods and procedures for calibration and metrology within a pharmaceutical environment

  • Knowledge of GMP guidelines and regulations

  • Familiarity with ISO standards

  • Analytical and problem-solving skills

  • Attention to detail, organizational skills, ability to multitask and follow through tasks to completion

  • Strong customer service and interpersonal skills

  • Working knowledge of computer applications including Outlook, Word, and Excel

  • Work independently and within a team environment

  • Ability to prioritize and organize work assignments

  • Must be able to lift and stack objects up to 50 lbs. occasionally, and frequently exert between 10-20 lbs. of force to lift, carry, push, and pull or otherwise move objects

  • Must possess the ability to climb, bend, lift, kneel, stoop, and extend arms overhead. Working from heights is required

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 (http://www.isotope.com/userfiles/files/assetLibrary/MET_MATTHEWS.pdf) 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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