QA Specialist

Location: Gurabo, PR
Date Posted: 10-19-2017
DESCRIPTION
Under the direction of the Manager, perform assigned duties in accordance to established company and corporate operating procedures, rules, and regulations as well as in accordance with current GMP guidelines. Monitor metrics effectively.  

RESPONSIBILITIES
  • Ensures that all external customer complaints and internal complaints from affiliates are handled, evaluated, investigated and documented in a timely manner.
  • Actively participate in projects, programs, safety and environmental training, GMP, SOP and others as required .
  • Identify opportunities to harmonize processes, improve the quality of processes and streamline processes.
  • Create a progressive monitoring process to ensure compliance of process, documentation and identify opportunities for improvement and streamlining.
  • Participate regularly with management team to identify solutions to common issues and prioritize solutions. 
QUALIFICATIONS
  • Minimum of 10 years related experience.
  • Bachelor Degree in  Engineering or Science (Pharmacy, Chemistry, Biology or related sciences)
  • Experience in Quality Assurance, Regulatory Compliance
  • Strong knowledge in FDA and International Regulatory requirements 
  • Technical Writing skills
  • Bilingual (English-Spanish)
 
 
Ultimate Solutions Corp. is an Equal Opportunity Employer.
 
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