Stability & Sample Management Coordinator
The Stability & Sample Management Coordinator is responsible for ensuring that all samples are entered into the Laboratory Information Management System (LIMS) and made available to the lab staff in a timely manner. Assists with the coordination and maintenance of stability studies as directed and in accordance to FDA, cGMP and Boston Analytical’s Standard Operating Procedures. This position reports to the manager of Stability and Sample Management. The Coordinator responsibilities include, but are not limited to, the following:
PRIMARY DUTIES AND RESPONSIBILITIES
- Responsible for receipt and entry of samples.
- Performs any combination of sample management tasks, including labeling, preparing for shipping, transporting to labs, inventorying and disposing.
- Reviews and verifies sample paperwork against samples to ensure accuracy and communicate discrepancies. Distributes sample information and paperwork.
- Verify data entry completed by others.
- Assists with stability studies as needed and directed. Including removal of samples from stability and verification of information.
- Properly handles, stores and disposes of hazardous materials according to OSHA and Boston Analytical procedures.
- Ensures all work performed strictly adheres to cGMP, company and client documents.
- Follows good documentation practices.
- Follows all safety rules and regulations.
- Follows all cGMP rules and regulations.
A high school diploma or GED is required, or an Associate’s degree in a scientific discipline preferred with 0-2 years of related work experience. Basic computer skills are required. Experience with cGMP is preferred. Knowledge of QC Chemistry or Microbiology testing is a plus.
Minimum Skills Requirements:
Must have the ability and skill to perform the detailed job requirements noted above competently, safely, accurately and proficiently. Self-starting motivated person who possesses excellent time management, the ability to adapt to change and organizational skills. Must have an ability to complete tasks efficiently and have excellent interpersonal skills to be able to clearly communicate with the manager. Must be detail oriented. Must be a team player with integrity and concern for the quality of Company products, services and staff members.