Quality Associate II at Baxter International

Round Lake, Illinois, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

HealthcareIndustries

Requirements

Demonstrates effectiveness in decision-making, problem solving, project management, and team leadership
Ability to assess and identify regulatory and quality risks in activities and processes
Ability to conduct gap analyses, implement Quality System policies and procedures, and manage compliance
Ability to manage and coordinate routine activities and projects
Ability to maintain appropriate quality metrics for trend analysis and reporting
Ability to analyze data, develop reports, and present during Management Reviews
Ability to routinely interact with corporate groups, external Pharma clients, inspectors, and auditors
Ability to support continuous improvement, CAPA, and lead multiple process/product improvement projects
Ability to assist in training staff, assure training requirements are met, and maintain records
Ability to write and approve change control assessments
Ability to manage activities of self and direct reports to achieve safety, quality, and production goals

Responsibilities

Manage and coordinate routine activities and projects for the facility’s documentation control team, plant change control, and supplier notice of change programs
Manage facility product/process change control system execution as change control process owner and TrackWise change control system administrator/subject matter expert
Provide training to plant resources on change control
Serve as plant representative and coordinate receipt, evaluation, and response to all Supplier Notice of Change surveys; support or lead associated change implementation projects
Manage facility documentation control system as team lead and TcU document system administrator
Facilitate the global policies and procedures gap analysis process and manage the document change process for plant SOPs, procedures, routers, and forms
Assure conformance to regulations and global policies/procedures with respect to change control, supplier notice of change, and documentation control
Manage documentation and data requests from Pharma clients, corporate product development, and other support functions
Maintain quality metrics for trend analysis and reporting to clients, facility, and corporate management
Interface with inspectors/auditors during regulatory inspections, Pharma client audits, corporate audits, and internal audits
Support continuous improvement and CAPA in area of responsibility
Identify, manage, and lead process/product improvement projects for quality, efficiency, and cost improvements
Support facility audit ready status efforts and assist other areas in achieving compliance with regulatory and corporate quality system requirements
Support the operation of the external audit control room during regulatory inspections, Baxter corporate audits, and pharma-partner compliance audits
Assist in training staff in area of responsibility and assure training requirements and records are up to date
Manage activities of self and direct reports in achieving defined safety, quality, and production goals

Skills

TrackWise

Change Control

Documentation Control

Quality Metrics

Trend Analysis

Gap Analysis

Risk Assessment

Project Management

Team Leadership

Supplier Management

Training

Baxter International

Provides essential medical products and services

About Baxter International

Baxter International provides a wide range of medical products and services essential for healthcare. The company operates in several areas, including critical care, hospital care, nutritional care, renal care, and surgical care. Its products are used in various settings, from emergency rooms to home healthcare, helping to meet the needs of patients and healthcare professionals. Baxter develops, manufactures, and distributes medical devices, pharmaceuticals, and biotechnology products, generating revenue through sales to healthcare providers and institutions. A key aspect that sets Baxter apart from competitors is its recent acquisition of Hillrom, which enhances its ability to offer comprehensive healthcare solutions. The company's goal is to improve care outcomes and increase access to healthcare through continuous innovation and a focus on patient needs.

Deerfield, IllinoisHeadquarters

1931Year Founded

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Parental Leave

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Commuter Benefits

Mental Health Support

Risks

Needle-free injection technology could disrupt Baxter's traditional injection-based therapies.

Shift to home healthcare may require Baxter to adapt its product offerings.

Growing digital health importance necessitates further investment from Baxter to stay competitive.

Differentiation

Baxter's acquisition of Hillrom enhances its comprehensive healthcare solutions portfolio.

Strong focus on patient-centric innovation sets Baxter apart in the healthcare industry.

Baxter's partnerships, like with Ayogo, leverage digital health for improved patient outcomes.

Upsides

Baxter's investment in Medically Home aligns with the growing home healthcare market.

Rising demand for personalized medicine offers Baxter opportunities for targeted therapies.

Expansion in telehealth supports Baxter's integrated healthcare solutions strategy.

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