Immediate opportunity for a Research Operations Associate, Nonclinical Report QC 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.
location: Newbury Park, California
job type: Contract
salary: $30.00 - 33.44 per hour
work hours: 9 to 5
education: Bachelors
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:
- Master's (MS) degree and/or 1+ years of related laboratory support experience, OR
- Bachelor's degree (BS) and/or 2+ years of related laboratory support experience, OR
- Experience supporting the quality control (QC) / review of nonclinical scientific reports
- 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.
skills: MS-WORD, MS-EXCEL, MS-Powerpoint, GLP (Good Laboratory Practice), GCP (Good Clinical Practice), Laboratory Information Management Systems (LIMS), QC Review, LIMS (Laboratory Information Management System
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
