Quality Assurance Specialist I

4 weeks ago

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

Cambridge Isotope Laboratories (CIL) has an outstanding opportunity for a Quality Assurance Specialist I to join the team responsible for the quality of several new and existing active pharmaceutical ingredients (APIs) and medical device components based onsite in our Tewksbury, 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.

Responsibilities:

  • Responsible for batch record review and release of finished products
  • Assist as a change management coordinator (e.g. document change plans, equipment change plans, facility change plans, IT change plans)
  • Authoring Annual Product Review Reports, as needed
  • Contributor to various QA Quality Program functions when needed (e.g. Deviation, CAPA, Supplier Management, Customer Complaints, biennial review, internal/external auditing, risk management, non-conformances, product returns, raw material review and release, etc.)
  • Responsible for periodic reconciliation of commercial API batch depletion
  • Perform room/line clearances
  • Label review and final inspections
  • Create logbooks and controlled forms
  • Perform GMP form reconciliation
  • Report authoring
  • Support other CIL organizations, as appropriate
  • Perform any related work as required

Requirements

  • Bachelor Degree in Chemistry/Sciences or quality assurance/management; equivalent applicable industry experience may be substituted for the degree requirement
  • Minimum of 5-8 years of experience in a GMP setting
  • Experience with Quality Assurance and knowledge and/or experience in ICH Q7, ISO 13485, is preferred
  • Excellent interpersonal, verbal and written communication skills are required
  • Attention to detail, organizational skills, ability to multitask and follow tasks through to completion. Work independently and in a team environment
  • Work is performed primarily in an administrative office environment
  • Experience with Microsoft Word, Excel, PowerPoint, Teams, Access, Adobe is a plus
  • Experience with electronic eQMS and ERP systems preferred

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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