What are the responsibilities and job description for the Quality Control Associate (LIMS/ELN/RIM) position at Infotree Global Solutions?
8 AM - 5 PM PT, will need an EW who can support Client core hours.
This will be an office based role, utilized for quality control of the instruments the Scientists are using.
We are looking for a candidate with skills to support the quality control / review of nonclinical scientific reports.
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 Client storage locations
Confirm Client 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 :
Masters degree and / or 1 years of related laboratory support experience, OR
Bachelors 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.
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.
Day to Day 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 Client storage locations
- Confirm Client 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
