Capa Coordinator

CAPA Coordinator Req : 18000EFS_en Location: Guayama, PR US Job Category: Quality Date Posted: 7/25/2018 11:49:52 AM Baxter International Description Perform trend analysis, review and approval of investigations reports. Follow up of commitments up to closure of investigations. Perform final review and determine acceptability by using product specifications, Master Batch Records, procedures and applicable documentation concerning to the manufacturing process and quality system elements. Support the quality monthly metrics presented inside and outside of Baxter Guayama. Coordinate the CRB and Management Review meetings and the Quality Quotient approach. Qualifications The candidate to fulfill this position needs to be capable of evaluating investigation reports considering all regulatory aspects to assure the same are adequate and complete. Need to have a wide GMP Knowledge and capable to perform trends to alert for actions to be taken and or potential risks. Leadership skills and quality oriented. Excellent oral/written communications and interpersonal skills. Ability to communicate at all levels within the organization. Good technical reports writing. Able to work under minimum supervision. Fully bilingual (written and verbal English and Spanish). Computer literate: PC Knowledge(Word, Excel and Power-point). Education: Essential: Requires a B.S. Degree in Science. Job Experience: Essential: At least three years of experience in the pharmaceutical industry. Desirable: Statistical knowledge and quality monitoring 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