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Compliance and Quality Specialist

San Juan, Puerto Rico · Biotech/Pharmaceutical · $14.50-14.85/hr.
Requirements:
  • Bachelor's Degree in Process and Quality Engineering, Industrial Engineering; in Management or Project Management, Quality Management, Business Administration, or related field.
  • Minimum (6) six months of experience performing similar functions desirable.
  • Mastery of Microsoft Office applications (Word, Excel, PowerPoint, and Outlook)
  • Excellent verbal and written communication skills in English and Spanish.
  • Excellent customer service skills, abilities to work in a team and relate to people at all hierarchical levels.
  • Excellent skills to transmit knowledge.
  • Ability to achieve results with minimal supervision, to work under pressure, set priorities and work on multiple tasks simultaneously, meeting deadlines and with a sense of urgency.
  • Ability to analyze data, processes and draw conclusions with attention to detail
  • Good skills to conduct investigations and audits.
  • Physical demands include when it is necessary to reach, push, pull and/or carry up to 20 pounds.
Duties:
  • Identify quality levels, ensuring that they are accurate, efficient, complete and in accordance with the criteria for a healthy operation, through the collection of documents, reports, and metrics.
  • Generate reports of plans and progress status of the Projects, Compliance and Quality department.
  • Carry out audits in accordance with the approved Annual Audit Plan, on the departments' compliance with their operational processes.
  • Prepare and send reports to the Department of Health as required by administrative ordinances and to manufacturers, as required.
  • Manage queries from leaders and employees on the establishment of practices and processes.
  • Coordinate and participate in training activities such as "Train the Trainer" aimed at developing the members of the Efficiency Committee and/or designated employees.
  • Manage table of manufacturer contracts with the required data and periodically send it to Management.
  • Manage the records of manufacturer contracts, customer complaints and recalls of manufacturers that are worked on.
  • Manage projects and register the assignment of the number of projects and other required information.
  • Prepare projects in Microsoft Project (scope of the project, folder with the required information).
  • Manage with clients the date of inspection by the Manager.
  • Prepare closing documents, improvement surveys to share with the client by email after the project is finished. Follow up as required.
  • Actively support cultural transformation processes.

Employer with Equal Employment Opportunity.

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