Technical Quality ConsultantReq # JR - 026679 Location Round Lake, Illinois, United States Job Category Quality Control Date posted 09/01/2020
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This person serves as one of the senior technical representatives within the QMS department(s) in the Quality organization. He/She is responsible for results in terms of management and implementation of the Product Development Lifecycle process tool and compliance to regulations and Baxter quality policies.
- Serves as one of the senior technical representatives in Product Development and Lifecyle Management (PDLM) in the Quality organization with responsibility for process results in terms of product quality, performance and safety
- Understands and assures conformance to regulations for Change Control Management (CCM), PDLM and TcU. Interfaces with regulators during inspections. This role is responsible for creation and maintenance of rule set for configuration management for drug and biologic products.
- Serves as the data architect for implementation for PLM systems to ensure where used and Product File reporting requirements are met
- May participate in or lead quality assessments of internal operations and suppliers to analyze compliance and assess risk
- Interacts frequently with plants, R&D, RA, Labeling and other internal supervisors, functional peer and senior leaders
- Identifies and leads continuous improvement projects with the objective of achieving quality, reliability and cost improvements
- Mentors, coaches, trains & develops more junior associates in the department and other functions
Required knowledge, skills, and/or abilities
- Thorough knowledge of CCM and PDLM procedures, regulations and standards
- Ability to mentor and serve as the internal technical expert
- Drug development and transfer knowledge
- Strong analytical and problem-solving skills
- Strong communication and leadership skills
- Strong interpersonal/communication/influencing/negotiation skills
- Strong project management skills
Education and Experience
- BS in science or engineering; advanced degree helpful
- 7 years in Quality, Manufacturing, Engineering or related field
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.
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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 to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.