Data Specialist – Quality Operations – Co-Op
Summary:
Responsible for the creation and maintenance of robust data gathering tools, prepare inputs and outputs to be used by functional areas throughout the site in order to make business decisions.
Essential Functions:
Develops, maintains and tracks Quality and Operations Key Performance Indicators (KPIs) and prepares meeting reports
Highlights and displays Quality KPI at floor, Extended Leadership Team (ELT) and Senior Leadership Team (SLT) level and conducts regular sessions among site staff to increase awareness on results and their impact on business
Builds relationships with Patheon’s leaders, Quality and Operations Management to understand their business objectives and priorities, and to develop supporting improvement initiatives;
Develops a deep understanding of Patheon’s quality sites’ capabilities continuously.
Analyzes/defines quality opportunities within the site Quality systems by conducting detailed operational, value stream and financial analyses, interviewing key personnel, and observing operations
Creates and executes specific proposals for quality and operations improvement projects including basic cost-benefit analysis based on assessment of opportunities.
Directly leads and/or manages improvement projects; ensures collaboration with supporting departments (i.e. Technical Operations, Training, Engineering, Quality Operations (QO), Business Management etc.) in order to achieve desired objectives.
Maintains projects on time and budget, manages expectations and risk, and ensures post-implementation benefits are realized.
REQUIRED QUALIFICATIONS
Education:
Minimum B.Sc. in Engineering or Computer Science in progress
Experience:
Knowledge of Good Manufacturing Practices (GMP) environment preferably in a QA or continuous improvement function.
Project Management experience
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills and Abilities:
Knowledge and understanding of Pharmaceutical Manufacturing, Good Manufacturing Practices and pharmaceutical processing regulations. Working knowledge of continuous improvement methodologies such as lean manufacturing or six-sigma, or comparable. Strong analytical and critical thinking skills. Strong interpersonal and communication skills – verbal, written, presentation. Established quality, regulatory, and production mindset including an appreciation for client service and the contract manufacturing industry. Works independently with minimal need for supervision. Ability to work with and influence a wide range of levels in the organization – from executive level to new associates. Ability to think and work at a “strategic” level as well as at a “project” level. Experience with Microsoft Office Applications including the ability to develop spreadsheets, presentations and reports. Proficiency in the English Language.
Core Competencies:
Put the Customer First – Think and act with a customer-centric mindset to deliver exceptional customer experiences. Own Your Results – Take personal accountability for all you do and always exercise good judgement. Find a Better Way Everyday – Be intellectually curious and embrace Practical Process Improvement (PPI).
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 (KPI’s) 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.
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