Quality Consultant: Process Optimization and Troubleshooting Expert

hace 4 semanas

Juncos, Puerto Rico Quality Consulting Group A tiempo completo
Job Summary

We are seeking a highly skilled Quality Consultant to join our team at Quality Consulting Group. As a process optimization and troubleshooting expert, you will play a critical role in driving quality improvements and ensuring operational efficiency.

About Us

Quality Consulting Group is a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry. Our company is dedicated to providing world-class services that meet the evolving needs of our clients.

Key Responsibilities:
  • Provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in operations, manufacturing, pilot plant or capital projects environment.
  • Work orders requestor, approver, may execute and document specific type of WOs (RSO) as applicable.
  • Change Controls assessor Change Control development & presenter CAPA proposal and implementation plan development & presenter URS's, RD's, DS's reviewer / approver /owner Maintenance Master Package (MMP) reviewer / approver / owner Test Runs / Protocols (PTCs) reviewer / approver / execution and/or support (may be author in very specific cases)
  • FAT's / SAT's author / reviewer / approver / execution and/or support Functional tests author / reviewer / approver / execution and/or support IOQ / PQ reviewer / execution and/or support P&ID and official drawings reviewer / approver / owner SOP & Forms: author / reviewer / approver /owner (equipment systems), reviewer (process) Job Plans development, reviewer and maintenance Spare parts reviewer, approver and maintenance Provide troubleshooting support as required by operations / engineering Analyze downtime incidents as per Equipment Failure, prepare recommendations, create action plans and execute to eliminate recurrence Participate actively in the support of High Skills equipment breakdowns, which could impact the operation with an extensive downtime Perform or review equipment / system Root Cause Analysis investigations Participate in risk assessment and continuous improvement initiatives (Kaizens, critiques, VSMs)
  • Generate or support the generation of One-point-lessons for systems / equipment Identify, evaluate, develop / design, plan and implement solutions for equipment / process improvement opportunities Development, execution and implementation of corrective and preventive actions (CAPAs) Assist in generation of training materials and in providing training on scientific, technical operations aspects of the equipment / systems
Requirements:

To be successful in this role, you must have the following qualifications:

  • Bachelor Degree in Engineering
  • Five (5) years of Previous experience in Engineering Knowledge in systems: MAXIMO – Owner (RSO) CDOCS – Editor, Owner, Reviewer, Approver, Data Verifier QMTS – Deviation Initiator and Owner, Change Control Owner GDMS – Owner
  • Availability for 1st shift (8AM a 5PM Monday to Friday)
Benefits:

We offer a competitive salary range of $85,000 - $110,000 per year, depending on experience. Additional benefits include:

  • Equal opportunity employer
  • Opportunity to work with a world-class team
  • Continuous learning and professional development opportunities
  • A comprehensive compensation package, including health insurance, retirement savings plan, and paid time off

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