Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description Business Title: Project Leader I - Quality Effective Date: 06.MAR.2023 Revision #: 1 Version #: 2.0, CURRENT Replaces: 20.MAY.2021 Summary: Manage a portfolio of Clients and update quality plans/quality performance for clients, supports product transfers from Pharmaceutical Development Services (PDS) and external to Commercial operations. Provide on floor Quality (Q) support, attend RAPIDS and performs deviation investigations. Participate in Failure Mode and Effect Analysis (FMEAs) and process improvements determined from trending data. Essential Functions: Manage multiple small-medium projects and/or improvement initiatives Lead risk analyses Assure continuous Quality improvement in plant related to trends from Quality systems Lead Quality initiatives, and provide Q support throughout the facility, quality assessments on process improvement activities such as Mini Ts, Kaizens Work with management to resolve project issues and resource constraints within the team. Support decision making on projects and future directions by trending deviations in Global Track Wise (GTW) Maintain positive team member interactions and manages conflict with assistance from Quality Manager Plan, monitor, and ensure completion of Metrics, CAPAs and quality approvals Support Quality investigations related to Site, Incoming material, Complaints and products Facilitate content of Quality Huddles, represent Quality at RAPIDs, and material under investigation Prepare Quality Agreements for approval Assure GTW compliance Manage client satisfaction by updating quality plans and coordinates customer requests Manage a portfolio of Clients of moderate to high complexity and will be the key contact Monitor Voice of the Client (VOC) and builds improvement plans Prepare quality presentations for Client meetings and present Support PAI or Client audits as necessary Support the implementation of Quality Agreements Maintain a safe working environment and report potential hazards. Perform alternating or rotating shift work (as required) REQUIRED QUALIFICATIONS Education: College/Technical School Diploma in related field Bachelor of Science (B.Sc.) in Chemistry, Pharmacy, Microbiology, or Engineering an asset Experience: Minimum 5 years of previous related experience in pharmaceutical/food/cosmetic industry, preferably in a QA function Minimum 2 years pharmaceutical development experience Project management experience or client management experience an asset Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered. Knowledge, Skills and Abilities: Strong self-motived individual. Ability to work independently, and within a team environment. Well organized and detail oriented with the ability to meet deadlines. Ability to prioritize multiple tasks. Strong interpersonal skills. Experience with Good Manufacturing Practices. Established quality, regulatory, and production mentality including an appreciation for client service and the contract manufacturing industry. Excellent written and oral communication skills. Proficiency using MS Office applications. Proficiency with 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. Effectively 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. Model 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 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 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. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. COVID-19 Vaccination Update for U.S. & Canada Colleagues All U.S. colleagues are required to disclose their COVID-19 vaccination status. New hires will be asked to disclose their vaccination status upon the first day of employment. U.S. new hires (including those in Field Sales, Field Services and Customer Support - Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. U.S. and Canada new hires in Clinical Research who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), Assistant CRA (ACRAs), all CRA and ACRA line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles. Canada new hires (including those in Field Sales, Field Services, and Customer Support Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. New hires in Field Sales, Field Services, and Customer Support Technical Applications will be asked to disclose their vaccination status upon the first day of employment. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
