Quality Assurance Validation Specialist

1 week ago


Somerset, United States Maxonic Full time
Job Overview

Position Title: Quality Assurance Validation Specialist

Employment Type: Contract (6+ months with potential for extension and conversion to full-time)

Location: Remote

Compensation: $45 per hour on W2 plus benefits

Work Schedule: Monday to Friday (40 hours per week)

Position Summary:

The Quality Assurance Validation Specialist plays a crucial role in ensuring compliance and operational excellence through the development and execution of validation protocols.

Key Responsibilities:
  • Develop and prepare validation protocols, including Installation Qualification (IQ) and Operational Qualification (OQ) documentation.
  • Generate comprehensive validation reports and factory acceptance test documents, demonstrating strong writing and attention to detail.
  • Interpret and analyze electrical and pneumatic control systems, technical design documents, and PLC code.
  • Conduct validation testing at customer sites, requiring travel of approximately 25% to 35%.
  • Document test results and manage deviations in accordance with industry standards.
  • Communicate validation outcomes effectively to project teams, including Quality Assurance, validation, and project management personnel.
  • Utilize troubleshooting skills and prior experience in control system programming, commissioning, and calibration.
  • Adhere to safety protocols, including confined space entry training.
  • Understand computer system validation principles, including GAMP 5 and CFR 21 Part 11 compliance.
Qualifications:
  • A minimum of a four-year degree in engineering, engineering technology, or a related field, or 5 to 7 years of relevant experience.
  • Possession of a valid driver's license.
  • Experience in preparation and execution of validation protocols is essential.
General Information:

The Quality Assurance Validation Specialist will work collaboratively with various engineering disciplines and external manufacturing partners to ensure successful project execution. This role requires meticulous documentation of field activities, including reports, labor logs, and expense reports.

About Maxonic:

Since its inception, Maxonic has excelled in aligning candidate strengths with client needs. Our dedicated team of recruiting professionals specializes in technology and is committed to finding positions that fulfill the long-term career aspirations of our candidates. We take pride in our extensive track record of successful placements and the strong relationships we maintain with our clients.


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