Sign up with

Already have an account? Log in here

Need some help?
Talk to us at +91 7670800001

Validation Specialist at QRC Group, Inc

Cidra, Puerto Rico, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Jan, 26

Salary

0.0

Posted On

04 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Validation, Injection Molding, IQ, OQ, PQ, Technical Writing, Metrology, Gage R&R, Calipers, Micrometers, CMM, Programmable Vision Inspection Systems, Standard Operating Procedures, Inspection Programs, Documentation, Product Development

Industry

Staffing and Recruiting

Description

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 Bachelor in Science Experience in FDA regulated industry 5 years of experience performing validation lifecycle activities Techical writting skills Read, write, speak and understand English and Spanish Additional Information All your information will be kept confidential according to EEO guidelines.

Responsibilities

The Validation Specialist will support the development, execution, and documentation of validation activities, including protocols, tests, and reports. They will ensure that all product development processes and relevant documentation are executed according to the agreed Product Specific Design and Development Plans.