This temp-to-perm position is responsible for providing study support to the Bioanalytical Sciences department compiling and evaluating data and preparing study reports. Individuals in these roles will work closely with assigned principal scientist or lead chemists, quality control group, and Supervisor of Clinical Bioanalysis. Individuals in this role require training and supervision of their day-to-day tasks and are able to coordinate simple study types progressing to more complex studies as they gain knowledge.
Review reports for missing, inaccurate, or improbable results, by verification of cited data against raw data.
Review reports for adherence to regulatory and/or client requirements as well as protocol requirements, and resolve data collection problems as needed.
Assist in the preparation of study reports by drafting reports, tabulating data, and incorporating tables and sections from contributing authors.
Format, proof, and edit Bioanalytical Science department documents such as sample analysis and validation reports, forms, SOPs and validation plans for correct grammar, punctuation and consistency in format and style.
Create the forms necessary for accurate documentation of GLP validations.
Create and maintain a style sheet for the Bioanalytical Sciences department.
Create templates for all routine documents.
Perform quality control duties such as reviewing data folders for accuracy and completeness.
Enter data into spreadsheets or other computerized systems.
Perform basic statistical calculations such as means, standard deviations, coefficient of variation and percent bias.
Maintain study records and archive study data and reports upon study conclusion.
Perform other duties as may be required by supervisor.
Bachelor’s degree required
Demonstrated experience utilizing a variety of general software applications (specifically Microsoft Windows, Word, and Excel).
Ability to learn and utilize specialty software applications (e.g. laboratory information management systems – LIMS).
One year of experience writing technical documents
One year of experience compiling and reporting technical data
Effective verbal and written communication skills including correct grammar, spelling, and punctuation.
Detail oriented; possess good planning and organizational skills; inquisitive.
Ability to interact with others in a cooperative, persuasive, and tactful manner.
Ability to read, understand, retain and apply knowledge of Good Laboratory Practices (GLP) and other study requirements.
Ability to type 50 WPM.
Willing to work overtime when necessary
Customer Focus : Makes customers and their needs a primary focus of one's actions; developing and sustaining productive customer relations.
Contributes to Team Success : Actively participates as a member of a team to move the team toward the completion of goals.
Builds Trust : Interacting with others in a way that gives them confidence in one's intentions and those of the organization.
Results Achievement : Takes prompt action to accomplish objectives; takes action to achieve goals beyond what is required; is proactive.
Safety Awareness : Identifies and corrects conditions that affect employee safety; upholds safety standards.