What are the responsibilities and job description for the Quality Control (QC) Specialist - Non-Clinical scientific reports position at Randstad Life Sciences US?
Immediate opportunity for a Quality Specialist to support the quality control / review of nonclinical scientific reports. This will be an office based role, utilized for quality control (QC) of the instruments the scientists are using.
Schedule / Shift : 1st shift, Mon.-Fri., 8am-5pm
Position Type : 6 mos. contract position; potential to extend
Job Summary : 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 Company 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.
Essential Duties and 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 Company storage locations
- Confirm Company 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
Qualifications :
