Associate Scientist
Advanced Bio-Logic Solutions Corp•Thousand Oaks, CA
12d•$30 - $35•Onsite
About The Position
Join a big biopharma leader's Translational Safety & Bioanalytical Sciences organization as a Nonclinical Report Quality Control Associate. In this vital onsite role, you will provide quality control of nonclinical reports generated by scientific staff, ensuring data integrity and regulatory compliance. You will interact with cross-functional teams to review documents and verify data accuracy, supporting critical filings.
Requirements
- Experience in quality control or review of nonclinical scientific reports
- Familiarity with laboratory data sources and regulatory documentation
- Demonstrated attention to detail and data integrity
- Strong organizational skills and ability to handle multiple priorities
- Proficiency with MS Office tools including Word, Excel, PowerPoint, Visio, and Outlook
- 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
- Master’s degree and/or 1+ years of related laboratory support experience
- Bachelor’s degree and/or 2+ years of related laboratory support experience
- Associate degree and/or 4+ years of related laboratory support experience
- 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
Nice To Haves
- Ability to solve complex technical problems independently in a fast-paced environment
- Effective verbal and written communication and interpersonal skills
- Working knowledge of regulatory (GLP and GCP) and pharmaceutical processes
Responsibilities
- Verify accuracy of experimental data in written reports against summary analysis files and electronic lab notebooks (ELNs)
- Ensure data within reports accurately reflect ELN sources and provide traceability to internal data repositories
- Coordinate and support the quality control (QC) process by accessing multiple internal databases (ELN, CDOCs, RIM, LIMS, etc.)
- Confirm presence of supporting data files in approved storage locations
- Ensure compliance with company report formatting and proofreading standards
- Own the QC review for toxicology and pharmacokinetic (non-GLP) study reports to support regulatory filings
- Assist with report formatting to meet regulatory filing requirements
- Review reports for accuracy versus lab data and source files
- Verify formatting and regulatory compliance of submitted documents
- Coordinate with scientific staff to resolve discrepancies
- Maintain thorough QC records and documentation
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What This Job Offers
Career Level
Entry Level
