Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, 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: 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. What will you do: 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) How will you get here? Education: Bachelor of Science (B.Sc.) in Chemistry, Pharmacy, Microbiology, or Engineering Experience: Minimum 5 years of previous related experience in pharmaceutical/food industry, preferably in a QA function Pharmaceutical development experience is an asset 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 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. 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. 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.
