Quality Associate IIReq #:
JR - 021632Location:
5/19/2020 2:24:36 PM
Baxter International Are you looking for a career that matters?
We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We're looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.
Learn more about how Baxter isAt the Intersection of Saving and Sustaining Lives. Position Summary
Responsible for providing Quality support and oversight via direct staff supervision or process/area responsibilities. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices.Job Responsibilities
Knowledge, Skill and Abilities
- Is dedicated to the continuous optimization of Change Control and other related systems. Provides regular suggestions for improvement and otherwise leads efforts to realize those improvements. Determine the logic, adequacy and effectiveness of processes, systems and related requirements.
- Leads the Change Control Board (CCB)-including both routine and ad hoc meetings as well as regular communication-to ensure adequate visibility and escalation of ongoing Change Control projects.
- Interacts regularly with Change Owners and Task Owners from various departments (e.g., Engineering, Manufacturing, Technical Services, Quality Control, et al.).
- Aids in the closure of high priority Change Controls.
- Serves as Subject Matter Expert (SME) for the Change Control Management (CCM) application within the TrackWise Quality Management System (QMS), and provides technical support for users of TrackWise.
- Generates reports from TrackWise on a regular basis and communicates due dates. Prepares data such that it is easily consumable by management, and presents Change Control metrics at regular intervals and upon request.
- Serves as a Quality Approver for Change Control records and provides guidance to Change Owners regarding the satisfactory completion of records.
- Obtains Baxter Certified Training Qualification and provides in-person or online training for Change Control. Contributes to the development of-or revision of existing-training material when necessary.
- Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
- Other duties, tasks or projects as assigned.
- Sustain a clean and safe work area using 6S principles
- Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)
Required Education and Experience
- Must be capable of understanding complex concepts related to projects from Engineering, Manufacturing, et al. Researches regulatory guidances, engineering standards, and other material when necessary to provide informed contributions to discussions regarding Change Control.
- Strong interpersonal skills and great attention to detail are necessary.
- Must be a strong team player with good problem solving, and good verbal and written communication skills.
- Must have the ability to manage people, encourage teamwork and drive decisions.
- Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
- Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
- Must have basic English written and oral communication skills adequate to communicate with other team members.
Bachelor's Degree in business/science or equivalent. 3-5 years exp. in Quality with a medical device / pharmaceutical company or other similarly regulated industry.Other Duties as Assigned
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Overtime is worked as required. 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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail toAmericas_TTA@baxter.comand let us know the nature of your request along with your contact information.