Job Description:
Cambrex
QC Data Review Scientist
US-IA-Charles City
Job ID: 2024-3973
Type: Regular Full-Time
# of Openings: 1
Category: QC
Cambrex - Charles City
Overview
The QC Data Review Scientist will be responsible for reviewing laboratory data and supporting documentation to ensure that they are compliant with SOPs, and compendial and cGMP requirements. This individual must have knowledge of instrument theory in order to thoroughly vet and review data and draw conclusions based on collected data.
Responsibilities
Adhere to all EPA, FDA, cGMP, cGLP DEA regulations and internal SOP's as they relate to the operation of the Quality Control lab and general operation of the chemical production facility.
· Follow all OSHA and company safety rules and practices.
· Reviews raw technical data provided by technicians, chemists and laboratory supervision to ensure accuracy, completeness and correct scientific conclusions have been drawn. Data may include Analytical Records, notebooks, logbooks, spectra, chromatograms, other instrument output and any other information supporting Analytical Records.
· Identifies data inaccuracies, incomplete inferences and works directly with laboratory staff to provide guidance and direction on the correction of laboratory data packages.
· Verifies and ensures that conclusions drawn on laboratory data are sound and accurate and representative of materials under examination.
· Provide off-shift coverage as required
· Maintain laboratory inventory and notebooks.
· Responsible for assisting in training employees as needed
· Coordinate and communicate project status
Qualifications
· BS/BA in Chemistry/Biology or related science field required
· Experience in a laboratory environment or quality assurance preferred
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