Senior Validation Specialist

hace 6 días


Juncos, Puerto Rico Mirus Consulting Group A tiempo completo
Job Description

We are seeking a highly skilled Senior Validation Specialist to join our team at Mirus Consulting Group in Humacao, Puerto Rico.

About the Role

This is an exciting opportunity for a senior quality assurance professional to lead our validation efforts and drive process improvements across our organization. As a key member of our team, you will be responsible for ensuring that all aspects of our operations meet the highest standards of quality and compliance.

The ideal candidate will have a strong background in quality assurance, validation, and project management, with experience working in a fast-paced environment. You will be expected to collaborate closely with cross-functional teams, provide guidance and support to junior staff members, and stay up-to-date with industry developments and best practices.

Responsibilities
  • Review and approve product masters
  • Approve process validation protocols and reports for manufacturing processes
  • Represent Quality on incident triage team
  • Approve Environmental Characterization reports
  • Release of sanitary utility systems
  • Approve planned incidents
  • Represent QA on NPI team
  • Lead investigations
  • Lead site audits
  • Own site quality program procedures
  • Designee for QA manager on local CCRB
  • Review Risk Assessments
  • Support Automation activities
  • Support facilities and environmental programs
  • Review and approve Work Orders
  • Review and approve EMS/BMS alarms
  • Approve NC investigations and CAPA records
  • Approve change controls
Requirements
  • Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience
  • Fluent in English and Spanish, including writing
  • Strong English technical writing skills
  • Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues
  • Problem solving skills
  • Experience working with dynamic cross-functional teams and abilities in decision making
  • Strong organizational skills, including ability to follow assignments through to completion
  • Strong leadership capabilities and experience applying GMP requirements in an operational setting
  • Ability to independently interact with various levels, drives tasks to completion, and is a self-starter
Salary

$120,000 - $180,000 per annum, depending on qualifications and experience.

We offer a competitive salary package, commensurate with your qualifications and experience. In addition to your base salary, you will receive a comprehensive benefits package, including health insurance, retirement plan, and paid time off.

Mirus Consulting Group is an equal employment opportunity employer and welcomes applications from qualified candidates of all backgrounds.



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