Quality Associate I

Baxter International Inc., assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.
1. Support Manufacturing, Engineering, and Quality Management departments with the development and implementation of computerized applications with a focus on the facility's paperless system implementation strategy2. Create and deliver fully tested computer programs and, when required, modify basic computer systems design on schedule and in accordance with requirements and departmental standards.3. Maintain working knowledge of software innovations and best practices4. Continue to develop computer system design and validation process and apply lean principles to improvements5. Must perform and support process validation, process capability, and process control studies on multiple product lines and processes.6. Must assist in the identification and development of process improvement projects including automation and computerization.7. Responsible for ensuring FDA regulations are met for system upgrades/replacements including 21 CFR Part 11 requirements8. Responsible for ensuring the quality of facility systems (validation):9. Writing and executing protocols and test cases for validations.10. Coordinating testing and documentation of projects.11. Documenting/executing changes to applications.12. Assisting/leading training for systems.13. Diversified knowledge of applied Statistical Analysis techniques, procedures and criteria to carry out measurements, process, and product capability study toward the development of new or refined equipment, materials, processes, instruments, and products.14. Ability to function effectively as a member of a team.15. Ability to communicate effectively in written and verbal form.16. Must have knowledge of both plant and department environmental health and safety regulations and comply with regulations accordingly.17. Must perform all other duties and responsibilities as determined by supervision/management.Qualifications
1. BS degree required, preferred in Computer Science or Engineering2. Knowledge of applications such as Allen-Bradley PLC/Wonderware, Windows NT/2000/XP preferred.3. Knowledge of database applications including SQL, Oracle, DB2 preferred4. Knowledge of reporting applications including Crystal Reports preferred5. Logical thought process.6. Self-motivated7. Ability to quickly learn and understand applications.8. Quality Assurance or Pharmaceutical industry experience desired.9. Candidates must meet visual acuity requirements as documented in the Baxter Cleveland Human Resources Procedure 1.04.As a global leader dedicated to building the best team in health care, Baxter offers competitive compensation and full benefits. To view other opportunities at Baxter, please visit our Careers@Baxter site. EOE M/F/D/V
REQUIREMENTS
PLC, FDA regulations, Quality Assurance, Crystal Reports, writing protocols, testing, process validation