My client, a global Contract Research Organisation, is currently recruiting for a Biopharmaceutical Data Review Scientist.
This position once onboarded will be remote enabled
· Ensures the quality of laboratory data and reports.
· Evaluates data to ensure compliance with analytical methods, client criteria, and Good Manufacturing Practices (GMP).
· Performs Release, Stability, non-routine and complex analytical data reviews ensuring scientific soundness and method validation.
· Reviews chromatographic/electrophoretic data and related documentation as specified by Standard Operating Procedures (SOPs).
· Reviews sample results tables and analytical reports for completeness and accurate representation of the data and report findings.
· Communicates with laboratory staff to proactively address the quality of laboratory documentation.
· Prepares statements noting deficiencies with the analytical data set or documentation.
· Reports deficiencies to the project leader for correction.
· Trains new data Reviewers and laboratory staff. Performs other duties as assigned, including SOP review and writing.
· Conducts consultations for quality records.
Education and experience
- BSc in Science or related field required
- 2+ years of QA/QC experience required (gaining thorough knowledge of chromatography, and ideally also knowledge of electrophoresis, ELISA, compendial tests)
- Thorough knowledge of SOPs and FDA, EMA Regulations to include GMP
- Strong verbal and written communication skills
- Strong technical knowledge including an understanding of laboratory procedures, methodology and standards
- Ability to independently review laboratory reports and analytical methods
- Strong attention to detail
For a full Job Spec and to apply for this role please call Zoe on +353 1 2784671 or e-mail firstname.lastname@example.org
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671