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Technical Data Reviewer

Location

Durham, NC, 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 / EU 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

  • As Technical Reviewer, you will be primarily responsible for performing an independent technical review of all test results and data for completeness, accuracy and compliance.
    • Scope: All analytical (small and large molecule entities) 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.
    • Method: Ensure 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. Ensure all issues/documentation is complete prior to approval.
    • Timeline: Provides accurate and timely delivery of data review and report any findings to the appropriate departments to support overall project due dates.

Qualifications

  • Requires Bachelor’s Degree in Biochemistry, Chemistry, Biology or related field.
  • 6+ years of laboratory testing experience, preferably in the pharmaceutical or biotechnology industries.
  • Experience working in GMP testing environment.
  • Knowledge and experience with a wide variety of analytical techniques and software such as HPLC, GC, FT-IR, ICP, NIR, UV/Vis, Karl Fischer, Total Particle Counters and Empower 3.
  • Experience working with LIMS and Empower 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, drug product and medical device testing, compendia methods (e.g. USP/NF, EP, JP), and method validation/qualification/transfer.
  • Experience in trending analytical data (method data and product data) is preferred.
  • Experience in trending environmental monitoring/clean room services data is preferred.
  • 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.
  • Strong interpersonal skills and teamwork to communicate with members within the quality and operations departments.