What are the responsibilities and job description for the Data Review Scientist position at United Pharma Technologies Inc?
Role: Data Review Scientist
Location: Iowa | Onsite
Job Overview
We are seeking a Data Review Scientist to support laboratory data review and ensure compliance with SOPs, compendial requirements, and cGMP standards. The ideal candidate will have strong chemistry knowledge and hands-on experience with analytical laboratory instrumentation, enabling them to thoroughly evaluate laboratory data, identify discrepancies, and confirm that scientifically sound conclusions have been reached.
Key Responsibilities
- Review raw laboratory data generated by technicians, chemists, and laboratory supervision to ensure accuracy, completeness, traceability, and scientific validity.
- Review analytical records, laboratory notebooks, logbooks, spectra, chromatograms, instrument output, and other supporting documentation.
- Identify data inaccuracies, discrepancies, incomplete conclusions, and potential compliance issues.
- Work closely with laboratory personnel to provide guidance and direction on the correction and completion of laboratory data packages.
- Verify that conclusions drawn from laboratory data are scientifically sound, accurate, and representative of the materials being tested.
- Support the maintenance and management of cGMP and controlled substance systems within QC/PSG laboratories in accordance with approved site procedures and protocols.
- Maintain effective communication across laboratory and cross-functional teams to ensure timely completion, review, and approval of laboratory documentation.
- Support alternative work schedules or shifts as needed to meet laboratory output and data-review requirements.
- Review laboratory investigations and supporting documentation for compliance and scientific adequacy.
- Review and interpret SOPs and ensure laboratory activities and documentation align with established procedures.
Required Qualifications
- Bachelor’s degree in Chemistry, Biochemistry, or a related scientific discipline.
- 3 years of experience in a pharmaceutical, biotechnology, or other cGMP-regulated environment preferred.
- Previous experience working in a laboratory environment.
- Strong understanding of analytical chemistry and laboratory instrumentation theory.
- Hands-on knowledge of analytical instruments such as:
- Other laboratory analytical instrumentation
- Strong scientific and chemistry knowledge with the ability to manage multiple priorities and project workloads.
- Excellent attention to detail and strong analytical and problem-solving skills.