Job Description

Summary:

Work closely with the Quality Management team to maintain metrics, track key performance indicators (KPIs), and review and revise Standard Operating Procedures (SOPs). Participate in departmental projects by drafting GMP documents and assisting in continuous improvement initiatives. Compile data, develop templates, and create trending reports to identify potential improvements and solutions.

Essential Functions:

• Review data from Global TrackWise (GTW) and Power BI platforms to develop trending reports for key Quality KPIs.

• Analyze data from various sources (Power BI, SAP, RFT metrics) to assess ongoing trends.

• Support quality efficiency improvement ideas, working collaboratively with the team to implement changes that enhance quality processes and procedures.

• Support procedure changes stemming from continuous improvement initiatives. This includes, but is not limited to creating training videos, revising SOPs, updating work instructions (Wis), and developing checklists.

• Provide support for the use of digital platforms within the Quality department, ensuring effective utilization.

• Assist in setting up and compiling presentations for Quality Operations meetings.

• Support complaint and deviation investigations, working with cross-functional teams to minimize the impact of deviations and develop appropriate corrective actions.

• Assist in small projects within the Quality department, contributing to project planning, execution, and completion.

REQUIRED QUALIFICATIONS

Education:

High school diploma/General Educational Development (GED) Certificate is required.

Working towards College diploma or University Degree in related field

Experience:

No eperience required.

Must be a minimum of 18 years of age.

Legally entitled to work in Canada.

Willing to undergo a background check

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills and Abilities:

Good written and oral communication skills. Strong accuracy and attention to detail. Ability to multi-task, meeting tight deadlines in a fast-paced environment. Knowledge of GMP and ability to follow SOPs an asset. Proficiency with Microsoft Office software applications. 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. 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:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about manufacturing/office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of up to 40 pounds; arm, hand and finger dexterity; visual acuity to operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Usually in a comfortable environment but with regular exposure to factors causing moderate physical discomfort from such things as dust, loud noise, bright lights, fumes, or odour. Use of Personal Protective equipment is required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator.

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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.