Validation Specialist

  • Contract

Company Description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!

Job Description

Validation Specialist with a strong knowledge of injection molding processes to support the development, execution, and documentation of validation activities (Protocols, Tests, Reports).

  • Familiarized with IQ, OQ and PQ validation phases for molds and equipment.
  • IQ: Confirmation of Drawings (including mold attributes), Equipment, and Procedures (mold setup and operating), mechanical assessment of mold and equipment.
  • Develop inspection programs and instructions for setup/positioning of tooling and parts. 
  •  Assuring that all product development processes and relevant applicable documentation are executed according to the agreed Product Specific Design and Development Plans.
  •  Updating and defining Standard Operating Procedures (SOPs).
  • Familiarized with Gage R&R methodology preferable.
  • Preferably, familiarized with metrology equipment and methods such as calipers, micrometers, CMM, Programmable Vision Inspections Systems.

 

Qualifications

  • BS Engineering
  • 3-5 years of experience
  • Computer Literacy
  • Bilingual (Spanish/English)

Additional Information

All your information will be kept confidential according to EEO guidelines.