Stability Management Associate
Stability Management Associate
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Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.)Job Description
How will you make an impact:
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.
What will you do
- 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 SQL and Sample Management Laboratory Information Management Systems (LIMS)
- 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 store them as electronic files
- File and organize stability documentation. Arrange for off-site storage
- Maintain a safe working environment and report potential hazards.
- Perform alternating or rotating shift work (as required)
How will you get here:
Education:
Bachelor of Science in Chemistry or related science.
Experience:
Minimum 2 years of previous Pharmaceutical experience with prior experience with Stability Studies and Sample Management.
Equivalency:
Equivalent combinations of education training and relevant work experience may be considered.
Knowledge Skills and Abilities:
Good understanding of laboratory concepts and testing methodologies. Hands on laboratory experience an asset. Knowledge of current GMP regulations ICH and other Regulatory guidelines. Proficiency in Microsoft Word Excel Access MS Project. Working knowledge of LIMS Nugenesis and SAP software. Good communication skills (verbal and written). Ability to be detail oriented and excellent organizational skills. Self-starter willingness to ask questions and be the true owner of the process. 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 harmoniously 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 SOPs and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management scheduling systemsetc.). Be client and patient consciousat 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. Models positive thinking and is open to change motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines of deliverables in a proactive manner. Consistently strives to improve skills and knowledge in related field.
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 SOPs and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management scheduling systemsetc.). Be client and patient consciousat 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. Models positive thinking and is open to change motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field.
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.
Benefits
We offer competitive remuneration annual incentive plan bonus scheme healthcare company savings plan and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation.
Required Experience:
IC
Employment Type
Full-Time
