Job Opportunities in United States


November 2, 2024

ProQualityNetwork

QA Specialist - 33658

Quality Assurance Specialist - 33658
Location: East of Puerto Rico Island
Work Type: 100% On-site
Shift: 3rd Shift
Duration: Approximately 3 Years
Open Position: 1

Position Summary
Join our client’s innovative Quality Assurance team to make a direct impact on manufacturing excellence! Under minimal supervision, the QA Specialist will perform key quality oversight activities that ensure compliance, safety, and operational integrity. If you have an eye for detail, a passion for quality, and experience in quality management, we want you on our team! Ready to make a difference? Apply today with your updated resume!

Educational and Experience Requirements
To qualify for this opportunity, you’ll need one of the following educational backgrounds, paired with directly related experience:
  • Doctorate Degree
  • Master’s Degree + 3 years
  • Bachelor’s Degree + 5 years
  • Associate’s Degree + 10 years
  • High School Diploma/GED + 12 years

Preferred Background: Sciences, with experience in Warehouse and Incoming QC operations, quality oversight, quality records (deviations, CAPAs, change controls), and data integrity principles.

Key Responsibilities
As a QA Specialist, you’ll play a vital role across several areas, including:
  • ✔️ Reviewing and approving product MPs
  • ✔️ Approving process validation protocols and reports for manufacturing
  • ✔️ Leading QA representation in incident triage
  • ✔️ Approving Environmental Characterization reports
  • ✔️ Overseeing the release of sanitary utility systems
  • ✔️ Approving planned incidents
  • ✔️ Representing QA on NPI (New Product Introduction) team
  • ✔️ Leading investigations and site audits
  • ✔️ Owning site quality program procedures
  • ✔️ Acting as a designee for the QA Manager on local CCRB
  • ✔️ Reviewing Risk Assessments
  • ✔️ Supporting Automation activities
  • ✔️ Supporting facilities and environmental programs
  • ✔️ Reviewing and approving Work Orders, EMS/BMS alarms
  • ✔️ Approving NC investigations and CAPA records
  • ✔️ Approving change controls
  • ✔️ Providing lot disposition and authorizing lots for shipment

Core Competencies
To excel in this role, you’ll bring the following skills and competencies:
  • Project Management: Demonstrated ability to drive projects to completion
  • Organization & Time Management: Strong organizational skills to handle multiple priorities
  • Leadership & Teamwork: Experience initiating and leading cross-functional teams
  • Influencing & Negotiation: Enhanced skills in leading, influencing, and negotiating
  • Technical Knowledge: Expertise in manufacturing and distribution processes, QA, QAL, validation, and process development
  • Regulatory Knowledge: Ability to interact with regulatory agencies effectively
  • Software Proficiency: Proficiency in word processing, presentation, databases, and spreadsheets
  • Communication: Exceptional written and verbal communication skills
  • Independence: Ability to work independently and engage with multiple organizational levels
  • Data Analysis: Advanced data trending and evaluation skills
  • Compliance Evaluation: Ability to assess compliance issues accurately

✨ Why Join Us?
Be part of a dynamic environment where your contributions make a tangible impact on quality and compliance. If you’re passionate about QA and ready to drive excellence, apply now inside the job description with an updated resume to start your journey with our client’s team!

Take the Next Step – Apply Today!

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