Supervisor-Manufacturing Quality Assurance

Company: Baxter International
Location: Round Lake
Posted on: June 18, 2022

Job Description:

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.Summary:Manage and coordinate routine activities and projects for an individual cell within the Manufacturing Quality Assurance team. This will include such activities as batch review and release, systems release, and nonconformance and CA/PA management while assuring compliance with established standards, regulations, specifications, and SOPs. Ensure that in process materials, finished products, packaging operations, and batch record documentation is in compliance with internal corporate/division/plant quality control programs, current Good Manufacturing Practices, current Good Documentation Practices, and external regulations. Assure the safety and quality of the products, processes, and systems.Essential Duties and Responsibilities:Will interact with manufacturing and supervision on a daily basis to address quality process or batch related concerns.Performs process compliance audits of all manufacturing areas to ensure quality of product/process is achieved.Develops, assigns and implements systems, procedures and policies to assure compliance with cGMP's and FDA regulations and company policies and procedures. Assess all plant systems, operations, products, processes, procedures, and documentation for adequacy and effectiveness to ensure Quality and Regulatory Compliance related to CA/PA.Applies problem solving logically and in an organized manner. Must have experience with Root Cause Analysis tools and the ability to apply tools to plant scenarios.Manages a team of individuals to drive correction, prevention, and improvement throughout the plant. Is responsible for results in terms of timeliness and conformance to regulations and Baxter quality policies.Manages documentation and data requests from Pharma clients, division, and product development and support functions related to QM Manufacturing Quality Assurance and batch release.Maintains appropriate quality metrics for trend analysis and Management Review.Must have good working knowledge of plant systems, processes, procedures, documentation, and products.Plays an active role on quality management teams within the organization.Must be able to manage multiple tasks and projects simultaneously.Manage activities of self and Technicians in achieving defined safety, quality, and production goals.Manages the control and storage of released printed materials and retention samples.Should be able to communicate at all Plant and Divisional levels.Assist in external and internal audits by collecting relevant information such as SOP's and routers.Performs process compliance audits for areas of responsibility.Review and approve batch documentation.Review and approve systems documentation.Perform final batch and systems release.Qualifications:Drives efforts to identify and implement process efficiencies in order to achieve established release goals.Seeks new ways to improve and streamline current business and system processes. Identifies, manages, and where appropriate, leads multiple process/product improvement projects with the objective of achieving quality, efficiency and cost improvements.Works with minimal supervision.Education and/or Experience:Bachelor's degree required, preferably in engineering or science. 3 or more years experience in Quality, Manufacturing or related field.#IND-USOPS#LI-DM1The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.Equal Employment OpportunityBaxter 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.EEO is the LawEEO is the law - Poster SupplementPay Transparency PolicyReasonable AccommodationsBaxter 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 NoticeBaxter 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. 071917

Keywords: Baxter International, Arlington Heights , Supervisor-Manufacturing Quality Assurance, Other , Round Lake, Illinois