Every day, millions of patients and caregivers rely on Baxter’s leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on Twitter, LinkedIn and Facebook.
The primary responsibility of the Data Integrity Specialist is to perform assessment of computer systems for the purposes of data integrity compliance as well as review computer systems (MIS, LAB & PLCs) that manage quality data and assess compliance with data integrity requirements. The analyst will identify the gaps, severity of the gaps and identify required remediation activities.
Essential Duties and Responsibilities
- Review of MIS, Lab and PLC computer systems.
- Meet / discuss systems with subject matter experts / system owners to understand use and criticality of systems.
- Report out on findings and identify remediation activities.
- Post-Secondary diploma/certificate in Computer Programming & Analysis or equivalent combination of related education and experience.
- 7-10 years of application support or development in a quality manufacturing environment, or preferrably 5 +years of application support or development experience with exposure to a quality manufacturing environment.
- Excellent written and verbal communication skills, to prepare and deliver complex information to a wide audience.
- Ability to work in a team environment as well as the ability to be self motivated and be able to work with minimum supervision.
- Strong ability to balance multiple priorities with excellent time management skills.
- Detail oriented with the ability to work under pressure.
- Intermediate proficiency MS Office applications including Word, Excel, Powerpoint.
- Strong analytical skills, to gather data to identify and address problems.
- Ability to manage validation of systems in an pharmaceutical environment.
- Essential to have skills and abilities in critical thinking & problem solving, effective communication, collaboration & teamwork and ability to deal with ambiguity.
- Familiarity with VMWare environment.
- Validation experience within a manufacturing environment.
Major Subjects / Specialties
- Database Administration required
- Computer Programming & Analysis required
- System / Application Security required
Type of Experience required:
- Database audit skills.
- Experience in a quality manufacturing environment.
- Experience with networked client server and stand alone computer systems
- Strong technical, analytical, and problem solving skills
- Understanding of application role based security
- Understanding of Microsoft Active Directory and Microsoft local account security.
- Ability to work in a fast paced environment.
- Familiar with standard concepts, practices, and procedures as a database administrator.
- Thorough understanding of validation process, preferably in a manufacturing environment.
A Career That Matters
Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
Thank you for your interest and application to Baxter. All applications will be reviewed and those candidates selected for consideration will be contacted directly.
Baxter is committed to creating and maintaining a barrier-free environment for all employees and customers. We believe in integration and equal opportunity and we are committed to treating all people with dignity and respect. Should you need assistance at any point during the recruitment process please contact Human Resources at 705-440-2704.