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Technical Data Reviewer

Location

Agawam, MA, USA

Department

Quality Assurance

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At Cambrex, it’s our people that set us apart. We work locally and have an impact globally. We’re committed to attracting, nurturing and retaining a passionate and talented team of experts in our fast paced and growing company. You will be valued and recognized. We offer an exceptional benefits package including medical, dental, vision, Life, STD, LTD, generous vacation in your first year, sick time, and retirement savings!

Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal – to improve the quality of life for our customers’ patients across the world.

Overview

The Technical Reviewer will work independently to provide a technical review for laboratory testing data in compliance with GMP standards and FDA / ISO regulations. This position specializes in various aspects of technical data and documentation evaluation and review, laboratory investigations, and a variety of routine and non-routine laboratory tasks.

Responsibilities

  • o Performs independent technical review of all test results and data for completeness, accuracy and compliance.
  • o All microbiological and environmental monitoring GxP testing performed on starting materials, raw materials, intermediates, drug substance, drug product, packaging components, customer samples, stability study samples, in-process testing/checks, etc.
  • o Ensures all testing was performed per approved SOPs/methods/protocols and comply with specifications by critically analyzing the reported data and results for accurate interpretation and conclusion. Ensures all issues/documentation is complete prior to approval.
  • o Provides accurate and timely delivery of data review and report any findings to the appropriate departments to support overall project due dates.
  • o Assists in laboratory investigations, out of specification (OOS) and aberrant result laboratory investigations
  • o Works with analysts and laboratory management to conduct and document the laboratory investigations.
  • o Writes testing plans associated with investigations.
  • o Ensures accuracy and compliance of the final investigation results and reports. Submit final report to laboratory management and QA for approval.
  • o Ensures timely closure of the laboratory investigation as required by procedure. Escalates issues which may impact timeline to laboratory and quality management.

Qualifications

  • Requires Bachelor s Degree in Microbiology, Biology, Environmental Science or related field.
  • 6+ years of laboratory testing experience, preferably in the pharmaceutical or biotechnology industries.
  • Experience in review of environmental monitoring reports, certifications, and risk assessments.
  • Experience working in GMP testing environment.
  • Knowledge and experience with a wide variety of microbiological and environmental monitoring techniques.
  • Experience working with LIMS preferred.
  • Demonstrated ability to think critically and to focus on details of execution.
  • Demonstrates ability to work effectively on problems of a diverse scope and with analysis/evaluation of data.
  • Expertise with respect to demonstrating theoretical understanding and providing effective evaluation of laboratory practices such as raw material, drug substance and drug product testing, compendia methods (e. g. USP/NF, EP, JP) and method validation/qualification/transfer.
  • Experience in participating and supporting regulatory inspections through explanations of methodologies, investigations, and/or laboratory systems is preferred.
  • Strong technical writing skills. Experience authoring and reviewing technical documents such as reports and protocols.