Validation Specialist

QRC Group, LLC • Cidra, PR

3d

About The Position

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.

Requirements

• Bachelor in Science
• Experience in FDA regulated industry
• 5 years of experience performing validation lifecycle activities
• Technical writing skills
• Read, write, speak and understand English and Spanish

Nice To Haves

• Familiarized with IQ, OQ and PQ validation phases for molds and equipment.
• Familiarized with Gage R&R methodology.
• Familiarized with metrology equipment and methods such as calipers, micrometers, CMM, Programmable Vision Inspections Systems.

Responsibilities

• Support the development, execution, and documentation of validation activities (Protocols, Tests, Reports).
• Develop inspection programs and instructions for setup/positioning of tooling and parts.
• Assure that all product development processes and relevant applicable documentation are executed according to the agreed Product Specific Design and Development Plans.
• Update and define Standard Operating Procedures (SOPs).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level