Reviews analytical data to ensure compliance with appropriate Standard Operating Procedures (SOPs), GLP and GCP regulatory agency guidelines and client requirements. Learn and apply knowledge of regulatory, SOP, and client requirements.
Essential Job Duties:
These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.
Supports applicable analytical data review and documentation to ensure quality standards are met and to verify compliance to applicable SOP and regulatory requirements.
Learn and apply knowledge of Watson, Nautilus, Analyst, and E-Workbook, Softmax Pro, and any other applicable software for review of electronic data.
Assists in following up on citation completion, organization and filing of data during the QC review process (inventory, mailboxes, Temporary Data Storage or Archives, etc).
Understands and has awareness of team priorities and timelines for client deliverables.
Interacts internally with other Bioanalytical teams to focus on client deliverables.
Learns to interpret and understand regulatory requirements (e.g., GLP, GCP), SOP requirements, and other guidance documents, as applicable.
Assists co-workers and internal customers with interpretation and understanding of SOP requirements. Reaches out for guidance when necessary.
Explores self-development opportunities.
Performs other related duties as assigned.
