Overview
Stability Management Associate – Co-Op Jobs in Mississauga, ON at Thermo Fisher Scientific
Full job description
Job Description
12 Month Co-Op Opportunity for an ELIGIBLE student in a Co-Op program – must maintain Co-Op eligibility until end of the Co-Op work assignment.
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.
Essential Functions:
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.
REQUIRED QUALIFICATIONS
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.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
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.
Standards and Expectations:
Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. M…
Title: Stability Management Associate – Co-Op
Company: Thermo Fisher Scientific
Location: Mississauga, ON
Category:
