Description
Review, trend, and transcribe Biologics stability data in preparation for regulatory filings.Duties:
- Retrieve data from LIMS (Laboratory Information Management System) database or other data repository
- Transcribe data into stability sections of regulatory filings, or perform 100% accuracy verification for previously transcribed data
- Review sample results within LIMS to identify incomplete testing
- Evaluate data
- Identify and plot product degradation trends
- Notify Stability Lead of any unusual findings or gaps in data trends
- Assist Stability Leads with various tasks as necessary
- Assist with sample handling duties as needed
- Data transcription and verification and LIMS sample review will be majority of workload
Skills Required:
- Ability to work in a highly regulated environment and learn/comply with GMP expectations
- Background in biochemistry, biology, chemistry, or related scientific discipline
- Basic understanding of results from typical bio-analytical testing: ie HPLC, Electrophoresis, ELISA, Compendial assay, etc.
- Ability to accurately transcribe data from Excel documents to MS Word
- Ability to thrive in a fast-paced environment and adapt to changing priorities
- Familiar with Microsoft Office Suite, and computer literate enough to quickly learn new systems
- Experience working in a GMP environment
- Understanding of normal pharmaceutical development processes
- Experience or understanding of ICH Q1A