Stability Management Associate - Co-Op

at  Thermo Fisher Scientific

SUMMARY:

Provide support to Laboratory Operations for stability studies. Responsible for all aspects of the stability sample program - initiation and management of the stability study as well as sample handling.

EDUCATION:

High school diploma/General Educational Development (GED) Certificate is required
Working towards a College Diploma or University Degree in a Science related field.
Current enrollment in B.Sc. would be an asset

EXPERIENCE:

Requires no previous related experience.

KNOWLEDGE, SKILLS AND ABILITIES:

Computer proficiency with Microsoft Office programs (e.g., Outlook, Excel, Word, Access). Good interpersonal skills (verbal and written). Ability to multi-task. Detail oriented with a focus on accuracy. Works well independently and in a team environment. Proficiency with the English language.

PHYSICAL REQUIREMENTS:

Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.

DISCLAIMER:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees

• Generate and maintain Stability Protocols based on expected customer requirements and in compliance with all current ICH regulatory guidelines.
• Work directly with project team, laboratory management and clients to define registered stability commitments for study design, testing requirements, and stability specifications.
• Receive and maintain inventory of stability samples.
• Responsible for proper labeling of stability samples and completion of all required documentation.
• Ensure all stability samples are stored at the appropriate temperature and humidity conditions.
• Responsible for the initiation of stability studies following the requirements of the stability protocol.
• Creation and maintenance of the Stability Schedules in LIM’s
• Prepare testing documentation and daily stability pull lists though the review of protocols.
• Responsible for pulling stability samples from the chamber on schedule.
• Submit and coordinate samples to Analytical Operations, Microbiological and outside testing facilities.
• Preparation of required documentation and arrangement for the shipping of sample send outs.
• Coordinate in-house testing of Special Request samples.
• Perform disposal of samples upon completion of stability studies.
• Generate stability summary reports.
• Scan stability documents and stores them as electronic files.
• File and organize stability documentation. Arrange for off-site storage.
• Maintain a safe working environment and reports potential hazards.