Quality Control Analyst I Req : 18000E9T_en Location: Guayama, PR US Job Category: Quality Date Posted: 7/18/2018 6:37:31 PM Baxter International Description(This section focuses on the main purpose of the job in one to four sentences) To provide a reliable, functional, and efficient quality control laboratory operation in terms of the state of validation, maintenance, backups and performance of the Laboratory Information Management Systems (LIMS and other) in accordance with Baxter Healthcare, Standard Operating Procedures (SOP's), United States Pharmacopeia (USP), European Pharmacopeia (EP), Japanese Pharmacopeia (JP), GMP and the 21 CFR Part 11 regulations. The Lab Systems Administrator primary job is to coordinate with the IT personnel to perform software installation, maintenance and hardware/software configuration so that it performs optimally within the validation software guidelines and to monitor and audit the state of these systems on a regular basis. Implement innovative system solutions for real time data collection related to different areas within the QA/QC department. Lead projects as required. Recommend and Managed LIMS system upgrades. Maintain LIMS and other Lab information management software Dictionaries updated. (This section contains a list of five to ten primary responsibilities of this role that account for 5% or more of the work. The incumbent will performed other duties assigned) Responsibility: Backup and Recovery. Desire Outcome: Regulatory Compliance Responsibility: Routing Schedule Maintenance. Desire Outcome: LIMS & other systems Support Responsibility: Troubleshooting. Desire Outcome: LIMS & other systems Support Responsibility: Failure Recovery. Desire Outcome: LIMS and other systems Support Responsibility: Data Analysis. Desire Outcome: LIMS and other systems Support Responsibility: Update specifications Desire Outcome: Regulatory Compliance Responsibility: Training on software applications Desire Outcome: LIMS Support Qualifications Qualifications:(List knowledge, skills, and/or abilities required) Good communication skills. Written and spoken English skills. Excellent interpersonal relations. IT or Quality Systems Computer experience. Education:Essential: High-school diploma Desirable: IT Technical degree or Bachelor degree (if applicable) Job Experience:Essential: A minimum of five years of quality systems/ software information management experience. Desirable: Data integrity principles exposure with document control and change control Experience. (if applicable) 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 Pay Transparency Policy Reasonable Accommodations 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_TTAbaxter.com and let us know the nature of your request along with your contact information. SDL2017
