Quality Associate - Day shift at Baxter International

Mississauga, Ontario, Canada

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Bachelor of Science in Chemistry or Biology
Knowledge of GMPs, and government regulations for drug products, biologics, and medical devices
Prior QA experience in the Pharmaceutical Industry
Knowledge of Canadian regulations for drug product, biologics and medical devices
Ability to use the Microsoft Suite of applications
Ability to build strong relationships with internal and external customers
Ability to work independently and prioritize
Strong data analysis and investigation skills
Excellent communication skills
General knowledge of Quality systems
SOP/Technical Writing experience
Knowledge of GMPs and Health Canada regulations for drug products, biologics and medical devices

Responsibilities

Provide technical expertise and guidance on quality systems, including quality management systems (QMS), document control, change control, and corrective and preventive action (CAPA) processes
Develop and maintain quality policies, procedures, and work instructions to ensure compliance with regulatory requirements and Baxter's quality policies
Collaborate with cross-functional teams to identify and implement quality system improvements
Implement and maintain quality system initiatives to ensure compliance with regulatory requirements and Baxter's quality policies
Conduct gap assessments and risk assessments to identify areas for improvement and develop corrective actions
Develop and maintain quality system documentation, including procedures, work instructions, and records
Work with the Mississauga QA and RA teams to ensure appropriate execution of Management Review
Manage and Maintain Canada-specific Agreements
Develop and deliver training programs to ensure employees understand and comply with quality systems and regulatory requirements
Provide guidance and support to employees on quality system-related issues
Lead audit readiness activities to assure Baxter Canada is in a state of audit readiness
Participate in internal audits and regulatory inspections to ensure compliance with quality systems and regulatory requirements
Develop and implement corrective actions to address audit and inspection findings
Support the Regional Hold coordinator to assure product holds are appropriately executed
Conduct Quality assessments of Returned product

Skills

Quality Management Systems

QMS

Document Control

Change Control

CAPA

Corrective and Preventive Action

Risk Assessment

Gap Assessment

Quality Policies

Regulatory Compliance

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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