- Leadership Experience
- Quality Assurance
- Microsoft Word
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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.
Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned):
Manages facility product/process change control system execution. Change control process owner and TrackWise change control system administrator / subject matter expert.
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.
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, and publishing of annual product reviews.
Bachelor's degree required, preferably in engineering or science (or equivalent work experience).
3-5 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, and Adobe Acrobat.
Must not be allergic to Penicillin or Cephalosporins.
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
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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.