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C&Q Specialist

Vega Baja, PR


Searching for C&Q Specialist with experience in the pharmaceutical and medical devices industries.  The candidate must have solid GMP and regulatory experience with expertise in equipment validations.
Duties and Responsibilities
  • Must possess a solid understanding of FDA Validation guidelines and industry best practice for this field; and be able to implement Validation standards on a daily basis
  • Implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards
  • Generate new specifications based on new regulations required by the implementation of a new manufacturing process.
  • Generates, executes, reviews, and complete qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
  • Prepares and coordinate qualification activities.
  • Communicate with the staff and management on ways of implementing plans and recommendations.
Minimum of 2 years of experience

Bachelor in Science or Engineering (BSME, BSEE, BSChE, BSIE preferred)

Additional Requirements
  • Problem Solving
  • Sense of urgency
  • Detail Oriented
  • Be flexible enough to travel to job sites when need arises.
  • Willing to work overtime including weekend depending ion the nature of work available.
  • Able to work with minimum or no supervision
  • Strong interpersonal skills and must work in a team
  • Fully Bilingual (English and Spanish)
Ultimate Solutions Corp is an Equal Opportunity Employer.
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