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Associate Research Operations, Nonclinical Report QC

Thousand Oaks, CA 91320

Posted: 01/17/2025 Employment Type: Contract Job Category: Scientific Job Number: 617177 Is job remote?: No Country: United States

Job Description

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 the 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 the 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

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.

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.

Pay ranges between $28-30.20/hr based on experience 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Thousand Oaks, CA

Ready to take your career to the next level in the vibrant city of Thousand Oaks, California? Nestled in the heart of Ventura County, this bustling city offers a perfect blend of suburban charm and urban amenities. With a strong job market, top-notch schools, and breathtaking views of the Santa Monica Mountains, Thousand Oaks is an ideal location for professionals seeking growth and fulfillment. Explore job opportunities near iconic sites like the Gardens of the World, catch a show at the Fred Kavli Theatre, or indulge in the local culinary scene featuring dishes from around the world. Join this dynamic community and unlock your potential in Thousand Oaks! Start your job search now to find your perfect fit in this captivating city.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.