Technical Data Reviewer
Posted on: January 22, 2023
The Technical Reviewer will work independently within a team to
provide a technical data 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 quality assurance tasks.
- 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 Microbiological and Environmental Monitoring GxP
testing performed in the laboratories at the Agawam, MA
- Method: Ensure all testing was performed per approved
SOPs/methods/protocols 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 adverse findings to the appropriate departments to
support overall project due dates.
- As a Technical Reviewer, may assist in laboratory
- Scope: Out of specification (OOS) and aberrant result
- Method: Work with analyst and laboratory management to ensure
investigations are completed per approved testing plans. -
- Timeline: - Support timely closure of the laboratory
investigation as required by procedure by ensuring testing is
reviewed promptly. Escalate issues which may impact timeline to
laboratory and quality management.
- Requires Bachelor's Degree in Biology, Microbiology, or related
- 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 Microbiological
techniques including but not limited to Sterility testing,
Bioburden testing, Microbial Limits, Endotoxin, and Microbial ID.
- Experience working with LIMS preferred.
- Demonstrated ability to work collaboratively in a team
- 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 and methods including compendial methods.
- Experience in authoring, revising, reviewing technical
documents such as methods, reports, and protocols.
- Experience in participating and supporting regulatory
inspections through explanations of methodologies, investigations,
and/or laboratory systems is preferred.
Cambrex is an Equal Opportunity / Affirmative Action employer and
will consider all qualified applicants for employment without
regard to race, color, religion, gender, sexual orientation, gender
identity, national origin, age, protected veteran status, or
Keywords: Cambrex, Springfield , Technical Data Reviewer, IT / Software / Systems , Agawam, Massachusetts
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