Specialist Manufacturing

hace 5 horas

Juncos, Puerto Rico Inteldot A tiempo completo

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

Administrative shift (8 hours)

Job Description:

Support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.

Job Requirements:

  • Manufacturing Experience
  • Hands on experience managing CAPA & Change Controls
  • Document revisions
  • Operating Systems: VEEVA

General Functions:

  • Work experience (manufacturing, process development, or quality assurance) in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, critical thinking, project management, and quality systems.
  • Project Management and/or Quality Management skills and experience. Demonstrated ability to coordinate and effectively participate in cross-functional project teams and deliver on schedule.
  • Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction.
  • Excellent communication skills, both written and verbal (including technical writing and presentation skills) in English, with ability to collaborate productively with technical and senior management staff.
  • Demonstrated ability to work autonomously, present data in an organized and logical manner, meet deadlines, prioritize work and communicate effectively.
  • Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.
  • Proficient with Microsoft Office Tools (Word; Excel; PowerPoint; Project, Teams, Outlook)
  • Experience managing quality records (deviations, CAPAs, CAPA-EV, Change Controls, Supplier Investigation Records) using TrackWise, or Vevaa or a comparable quality system

Education:

  • Doctorate or Masters + 2 years of Manufacturing operations experience or Bachelors + 4 years of Manufacturing operations experience or Associate + 8 years of Manufacturing operations experience or High school/GED + 10 years of Manufacturing operations experience.
  • Preferred background: Science or Engineering

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