Description:
Note:
This is an ONSITE position reporting to Thousand Oaks location 100%. Local Candidate Only

Title: Associate Research Operations, Nonclinical Report QC
As part of the Translational Safety & Bioanalytical Sciences organization (TS&BA), this vital role is responsible for the quality control (QC) of nonclinical reports generated by the scientific staff in TS&BA and the Pharmacokinetic and Drug Metabolism (PKDM) groups. This role will provide oversight of nonclinical report QC, contribute to data integrity review of electronic lab notebooks (ELN) and assure compliance with operational procedures. Responsibilities include working across functional departments to support TS&BA and PKDM staff to assure data integrity of regulatory documents against study reports, study reports (nonGLP and GLP) against ELNs or other source data. The candidate would benefit from prior experience in a nonclinical drug safety or pharmacokinetic lab environment and requires the ability to work in a dynamic team-based culture. This position reports to a Principal Scientist in TS&BA.

Role Responsibilities

• Confirm the accuracy of experimental data contained in written reports against final summary analysis files and ELN, e.g., QC of text, tables and figures.
• Confirm that experimental data used in reports to support conclusions accurately reflect ELN data sources (traceability to various internal data repositories or systems or source data verification)
• Coordinate, organize and support the QC process by accessing multiple internal databases (e.g., ELN, CDOCs, RIM, LIMS, etc.) to complete the QC task.
• Confirm presence of supporting data files (raw and analyzed) in approved storage locations
• Confirm report formatting requirements are followed (i.e. table/figure titles and descriptions), including proofreading
• Own the QC review of reports for different types of toxicology and pharmacokinetic nonclinical (non-GLP) study types to support IND-filings with a focus on ensuring data quality and integrity.
• Ability to aid in report formatting including regulatory filing requirements

Preferred Qualifications:

• Ability to solve complex technical problems and work independently in a fast-paced environment.
• Effective verbal and written communication and interpersonal skills.
• Attention to detail.
• Knowledge of MS Office tools, such as Word, Excel, PowerPoint, Visio, and Outlook
• Knowledge of regulatory (GLP and GCP) and pharmaceutical processes is recommended.

Basic Qualifications        

• Master’s degree and/or 1+ years of related laboratory support experience, OR
• Bachelor’s degree and/or 2+ years of related laboratory support experience, OR
• Associate degree and/or 4+ years of related laboratory support experience, OR
• High school diploma or GED and 6 years of related laboratory support experience
• Complete understanding of technical principles and concepts to perform a wide range of work in a role.

Top 3 Must Have Skill Sets:        

• Ability to solve complex technical problems and work independently in a fast-paced environment.
• Effective verbal and written communication and interpersonal skills.
• Attention to detail.
• Knowledge of MS Office tools, such as Word, Excel, PowerPoint, Visio, and Outlook
• Knowledge of regulatory (GLP and GCP) and pharmaceutical processes is recommended.

Pay Rate  between $29 - $33/Hr on W2 based on experience.

"This posting is for Contingent Worker, not an FTE"