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Whitby, Ontario, Canada
Onsite
Work Schedule
First Shift (Days)Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description
Responsible for the oversight, deployment, administration, maintenance, and support of laboratory applications, learning management systems, and associated standalone and enterprise systems within a regulated pharmaceutical laboratory environment. Serves as the SM LIMS Site Subject Matter Expert and supports compliant administration of SF LMS.
Essential Functions:
REQUIRED QUALIFICATIONS
Education:
Bachelors Degree in Science or Computer Science or similar field of study. Equivalent combinations of education, training, and relevant work experience may also be considered.
Experience:
Minimum 10 years laboratory experience.
Minimum 6 years laboratory experience in use of lab software applications (example include: Empower, Chromeleon and LIMS application), Knowledge of 21CFR Part 11 compliance.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills and Abilities:
Excellent verbal communication and written, with active listening and summarization skills. Sound knowledge of Good Manufacturing Practices. Sound understanding of Standard Operating Procedures. Business process knowledge of Quality Management, Lab Operations, and Lab Information Management Systems. Ability to make quality decisions. Demonstrated computer proficiency with Microsoft Office programs. 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 SOP's 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 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. 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 SOP's 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 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. 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.
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
Compensation
The estimated annualized pay range for this position in Ontario is $69,400.00–$104,050.00.