
Quality Associate III - Change Control
Descrição geral
É aqui que você faz a diferença na segurança de nossos pacientes. Como membro da equipe de Qualidade da Baxter, você desempenhará uma função essencial em nossa missão de salvar e prolongar vidas. A qualidade é importante em todo o ciclo de vida do produto e trabalha de forma colaborativa com todas as áreas da organização. Como a Qualidade afeta tudo o que a Baxter faz, uma função na Qualidade oferece muitas oportunidades de crescimento, aprendizado e uma carreira de sucesso que afeta a vida das pessoas todos os dias.
-
Suporte aos pais
-
Educação continuada/ Desenvolvimento profissional
-
Benefícios de saúde e bem-estar dos funcionários
-
Férias remuneradas
-
2 dias por ano para trabalho voluntário
Perfil de sucesso
O que torna um membro da equipe de qualidade da Baxter bem-sucedido? Confira algumas das principais características que estamos procurando e veja se o seu perfil se encaixa.
- Orientado para os detalhes
- Aprendiz contínuo
- Corajoso
- Colaborativo
- Pensador crítico
- Influente
Quality Associate III - Change Control
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.
Your role at Baxter
Manage and coordinate routine activities and projects for the facility’s documentation control team, and the plant change control and supplier notice of change programs. Maintains appropriate quality metrics for trend analysis and reporting to clients and internal management. Assesses and identifies regulatory and quality risks in activities and processes; conducts gap analyses, implements Quality System policies and procedures, and manages compliance in areas of responsibility. Leads multiple process/product improvement projects. Demonstrates effectiveness in decision-making, problem solving, project management, and team leadership.
What you will be doing:
Manages facility product/process change control system execution. Change control process owner and TrackWise change control system administrator / subject matter expert. Provide training to plant resources on change control.
Serves as plant representative and coordinates receipt, evaluation, and response to all Supplier Notice of Change surveys. Supports or leads associated change implementation projects.
Manages facility documentation control system. Team lead for documentation control team. System administrator of the TcU document system. Facilitates the global policies and procedures gap analysis process. Manages the document change process for plant SOP, procedures, routers, and forms.
Understands and assures conformance to regulations, and global policies and procedures with respect to change control, supplier notice of change, and documentation control. Conducts gap analyses, implements quality system policies and procedures, and manages compliance in areas of responsibility as plant subject matter expert.
Manages documentation and data requests from Pharma clients, and corporate product development and other support functions. Maintains appropriate quality metrics for trend analysis and reporting to clients, and facility and corporate management. Analyzes data, develops reports, and presents during Management Reviews.
Routinely interacts with other corporate groups and external Pharma clients from around the world. Interfaces with inspectors/auditors during regulatory inspections, Pharma client audits, corporate audits, and internal audits.
Supports continuous improvement and CAPA in area of responsibility. Identifies, manages, and where appropriate, leads multiple process/product improvement projects with the objective of achieving quality, efficiency and cost improvements.
Supports facility audit ready status efforts for assigned areas and assists other areas within the facility achieve compliance with regulatory and corporate quality system requirements.
Supports the operation of the external audit control room operation during regulatory inspections, Baxter corporate audits, and pharma-partner compliance audits.
Assists in training staff in area of responsibility and assures training requirements are met and records are up to date.
Assists and writes change control assessments and have the ability to approve other change controls.
Manage activities of self and direct reports in achieving defined safety, quality, and production goals.
Assists department in performance of internal compliance audits, collection and analysis of management review metrics, data review, complaint reports, quality escalations, and publishing of annual product reviews
What do you bring:
Bachelor's degree required, preferably in engineering or science (or equivalent work experience).
3 or more years experience in Change Control, Supplier Quality, Quality Assurance, Documentation Control, or QC/QA analysis.
Must have good working knowledge of plant systems, processes, procedures, documentation, and products.
Knowledge of global Regulatory and Quality requirements for the manufacture of drugs.
Exceptional organizational skills and ability to plan and implement resolutions to complex, technical problems.
Ability to effectively manage multiple, concurrent projects with minimal direct supervision.
Ability to effectively communicate verbally and in writing with all levels of the organization and with external clients. Good interpersonal/influencing/negotiation/leadership skills..
Proficiency with computer-based systems and software such as Microsoft Access, Excel, Word, PowerPoint, TrackWise, TcU, GME, SmartSheets and Adobe Acrobat.
Must not be allergic to Penicillin or Cephalosporins.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $88,000 - $121,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
#LI-AR1
US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Know Your Rights: Workplace Discrimination is Illegal
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
Endereço

Round Lake, IL 60073
United States of America Explorar agora
Conteúdo Relacionado
-
Employee Benefits Our comprehensive benefits options reflect the value we place in our employees. March 28, 2024
-
People of Baxter The people of Baxter are men and women who make a difference at work and in their communities. March 28, 2024 Read Time: 5 min. Our Stories - Hub Employee Stories Article
-
Nossa Separação Proposta Planejamos separar nossa Unidade Global de Cuidados Renais em uma empresa independente. Descubra o que isso significa para você. May 03, 2024 Related Content - SR_JD
-
Áreas de Carreira Explore nossas várias opções de carreira e descubra aquela que melhor se alinha aos seus talentos e objetivos profissionais. March 05, 2024 5 Minute Read Related Content - SR_JD Our Stories - Hub Employee Stories Career Advice Article
-
Como se Candidatar Aprenda dicas para se preparar melhor para o processo de inscrição. March 05, 2024 Read Time: 5 min. Related Content - SR_JD Featured Stories - Hub Our Stories - Hub Career Advice Article
-
Our Culture At Baxter, we intersect products with healthcare professionals and caregivers. Each employee finds support hroughout their journey, fostering career development and prioritizing well-being through programs, resource groups, and events. Our collaborative environment celebrates diversity and encourages growth. March 05, 2024 Read Time: 5 min. Our Stories - Hub Employee Stories Culture Employee Wellness Article
-
Diversity, Equity & Inclusion We prioritize relationships and take time to get to know one another here at Baxter. Our commitment to driving diversity, equity, and inclusion is at the forefront of everything we do. We foster cultural awareness and community through programs, and employee resource groups, that celebrate and support our differences. March 05, 2024 Read Time: 5 min. Our Stories - Hub Corporate Responsibility Business Resource Groups DE&I Article
-
Global Business Solutions Global Business Services (GBS) is the central hub of support for Baxter Healthcare's internal operations, offering a wide range of services to streamline business functions and improve efficiency. GBS encompasses Finance, IT, Human Resources, Procurement, and Supply Chain Management, ensuring seamless operations and maintaining Baxter's commitment to delivering quality products and services to patients worldwide. March 05, 2024 Read Time: 5 min. Our Stories - Hub Employee Stories Article
Junte-se à nossa comunidade de talentos
Agradecemos seu interesse em uma carreira na Baxter e gostaríamos de conhecê-lo. Participar da nossa comunidade de talentos é uma ótima maneira de estar conectado, aprender mais sobre a Baxter e ajudar nossos recrutadores a te encontrar caso houver uma oportunidade que se alinhe com sua experiência, habilidades e interesses.