Quality Control Documentation Specialist

Cambridge Isotope Laboratories, Inc. Andover , MA 01810

Posted 1 week ago

Cambridge Isotope Laboratories, Inc. (CIL) has an outstanding opportunity to work as part of the Quality Control team in a fast-paced environment based onsite in our Andover, MA location with possible travel to/from our Tewksbury, MA location. CIL with headquarters in Tewksbury, MA, is the worlds premier producer of stable isotope labeled compounds and a world leader in the field of stable isotope separations. CIL has over 600 employees with laboratories in the U.S., Canada, France and Germany. CIL is a subsidiary of the Otsuka Pharmaceutical Group.

The QC Documentation Specialist is responsible for performing the data review for the release of regulated and/or non-regulated materials including raw materials, in-process and finished formulations under general supervision and in accordance with standard operating procedures (SOPs). The QC Documentation Specialist also compiles data for documentation of test procedures, performs investigations, and prepares reports.

Responsibilities:

  • Review data for release of GMP/ISO and/or non-regulated materials
  • Follow documented procedures
  • Document test data as required
  • Write test procedures and SOPs as required
  • Perform investigations as required
  • Prepare reports as required

Requirements

  • BS degree in Chemistry, Chemistry Informatics or other relevant science degree
  • 3 or more years of relevant industry experience (GC,GC/MS, NMR or HPLC experience a plus)
  • GMP and/or ISO experience preferred
  • Hands-on experience with Biovia LES/LIMS system strongly preferred
  • Must be able to handle multiple tasks, take initiative, follow through
  • Must possess strong verbal and written communication skills
  • Must be able to work effectively independently and as part of a team

Benefits

CIL offers a competitive salary and a comprehensive benefits including generous paid time off, health insurance with no in network deductibles, Long Term Incentives and 6% matching 401K plan.

CIL is an EEO/Affirmative Action employer.

Learn more about us on our website: www.isotope.com

About us:

As the leading company in a niche scientific market, Cambridge Isotope Laboratories, Inc. supplies over 15,000 products to 30,000 research customers around the world and works with cutting edge researchers in clinical diagnostics, metabolic research, proteomics, environmental testing, protein discovery, nuclear medicine, drug development, metabolomics and industrial research. CIL has had consistent growth and profitability for over 40 years. 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 as pioneering research groups that have expertise in product development and drive market growth.

Cambridge Isotope Laboratories, Inc., with headquarters in Tewksbury, MA, is the worlds premier producer of stable isotope labeled compounds and a world leader in the field of stable isotope separations. CIL has over 600 employees with laboratories in the U.S., Canada, France and Germany. CIL is a subsidiary of the Otsuka Pharmaceutical Group.

For over 40 years, CIL has specialized in the development, production, and marketing of stable isotopes and chemical compounds labeled with stable isotopes. Join us for excellent career opportunities as we drive the expansion of market applications with innovative product development.

Learn more about us on our website: www.isotope.com

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Quality Control Documentation Specialist

Cambridge Isotope Laboratories, Inc.