Specialist Quality Control 34863

hace 5 horas

Juncos, Puerto Rico Inteldot A tiempo completo

Inteldot has over 14 years of experience in the life sciences industry, with allocations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Job Description

Under general direction, functions as the technical specialist for testing and development in areas of molecular biology and microbiology.

Administrative Shift

Requirements

  • Laboratory experience in a GMP environment within the Pharmaceutical and/or Biotech industry
  • Scientific Data Analysis
  • Strong Technical Writing (English and Spanish) mainly focused
  • Strong knowledge in Microsoft Excel as a Tool for Data Analysis
  • Good Communication skills
  • Project Management
  • Knowledge in Computer System and Method Validation (Experience preferable)
  • Strong knowledge and experience with quality process management
  • Basic Knowledge on equipment preventive maintenance and troubleshooting
  • Ability to develop inspection or qualification protocols in a short timeframe period.
  • Strong negotiation skills
  • Preferable Scientific Background (Science or Engineering) with experience in Pharmaceutical Industry, Quality Control, Laboratory Testing, Project Management and Quality processes.

Functions:

  • Responsible for providing technical guidance, provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise.
  • Resolve technical issues and troubleshoot for assays as necessary
  • Ensure lab compliance which includes Implementing procedures that enhance GMP, GLP and safety.
  • Manage existing and/or develop and implement new programs, processes and methodologies.
  • Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact.
  • Approve lab investigations, Lead audit teams
  • Serve as subject matter expert to develop technical training.
  • Perform routine work in a specific area of responsibility as necessary.
  • Represents the department/organization on various teams, independently responsible for following through on multi-site action items.
  • Interact with regulatory agencies regarding area(s) of responsibility including written responses.
  • Resolve issues with outside resources.
  • Performs special projects as requested by supervisor.

Education:

  • Doctorate or Masters + 2 years of directly related experience or Bachelors + 4 years of directly related experience or Associate + 8 years of directly related experience or-High school/GED + 10 years of directly related experience.
  • Preferable Scientific Background (Science or Engineering).
  • Preferable experience as Microbiologist, Chemist, Biochemistry, Molecular Sciences, or Chemical Engineering

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