Reviews analytical data to ensure compliance with appropriate SOPs, GLPs, regulatory agency guidelines and client requirements. This position is within the Bioanalysis Department that supports the drug development process for our customers utilizing LCMS technologies.
- Assists co-workers and internal customers with interpretation and understanding of regulatory requirements (e.g., GLPs), SOP requirements, and other guidance documents, as applicable.
- Reviews data to ensure quality standards are met and to verify compliance to applicable SOP and regulatory requirements.
- Maintains and seeks to expand a strong working knowledge of regulatory requirements (e.g. GLPs), SOP requirements, and other guidance documents. Applies existing knowledge to data review tasks.
- Maintains a working knowledge of client SOPs and requirements. Applies knowledge to data review tasks.
- Collects error tracking data for items reviewed.
- Monitors citation trends in eQA and performs follow-up actions with respondents, management, or others, if needed, to prevent recurring citations, problems, or errors.
- Completes self-development opportunities.
- Performs other related duties as assigned.
- Bachelor of Science/Arts (BS/BA) degree.
- Ability to efficiently use basic software (e.g., Word, Excel, PowerPoint).
- Experience may be substituted for education. For example, a two-year Associate degree plus 2 years applicable experience may be substituted for a BS/BA degree
- One year of laboratory, data review, or related experience with a BS/BA degree.
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