Specialist QA

Location: Caguas, PR, Puerto Rico
Date Posted: 09-01-2017
SPECIALIST QA

 
Description
 
Seeking a Specialist QA to perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision. Candidate must possess Regulatory Experience in the Pharmaceutical, Biotechnology or Medical Devices industry.
 
Responsibilities
 
•Approve process validation protocols and reports for manufacturing processes.
•Request quality on incident triage team.
•Support Automation activities
•Release of sanitary utility systems.
•Represent QA on NPI team.
•Review and approve MPs.
•Approve environmental characterization reports, planned incidents and change controls.
•Provide lot disposition and authorize lots for shipment.
•Approve NC investigations and CAPA records.
•Review and approve EMS/BMS alarms.
Skills and Qualifications
  • PROFICIENT KNOWLEDGE of MMPs and WOs
  • KNOWLEDGE WITH MAXIMO
  • EXPERIENCE IN commissioning documentation
  • KNOWLEDGE IN ASEPTIC FILLING PROCESS
  • Initiate and lead cross functional teams
  • Presentation skills
  • Good interpersonal skills and problem solving
  • Project Management skills
  • Strong organizational skills
  • Fully bilingual: oral and written
  • Leadership and team-building
Requirements
  • Doctorate degree in sciences or Master's degree in sciences and 3 years of directly related experience or Bachelor's degree in sciences and 5 years of directly related experience
Integrated Technology and Compliance Services is an Equal Opportunity Employer
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