Quality Control Documentation Specialist

Cambridge Isotope Laboratories, Inc. (CIL) is searching for a Quality Control Documentation 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 Quality Control 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 products undergeneral supervision and in accordance with standard operating procedures (SOPs). The QC Documentation Specialist maintains the Quality Control document system, paper and electronic, including but not limited to laboratory notebooks, logbooks, and controlled forms, and electronic data. They may also compile data and prepare reports for purpose of trending or support for investigative purpose.

Responsibilities

• Review batch data for release of GMP/ISO and/or non-regulated materials by ensuring the product meets set standards
• Review data, including raw data, laboratory notebooks, logbooks, and forms, for completeness and accuracy, including audit trails and electronic data
• Train on and follow documented procedures under GMP guidelines
• Compile data for trending purposes, i.e. cycle times
• Author or edit test procedures and SOPs
• Support investigation team by compiling or reviewing related data
• Prepare summary or trend reports
• Write deviation, CAPA reports, including root cause analysis and implementing appropriate corrective actions
• Track and maintain laboratory notebooks, logbooks, controlled forms, spreadsheets, training records, and other QC related documents
• Train others on practices of data review and documentation