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CSV Specialist - Incoming at QRC Group, Inc

Manatí, Puerto Rico, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Dec, 25

Salary

0.0

Posted On

20 Sep, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Commissioning, Equipment Qualification, Computer System Validation, Pharmaceutical Manufacturing, Laboratory Experience, PLC Experience, Industrial Computers, Validation Methodologies, Data Collection Software, cGMP, GAMP, SDLC, FDA Regulations, 21 CFR Part 11, Data Integrity Regulations, MS Project Management, MS Visio

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 CSV Specialist providing commissioning, equipment qualification (IOQ), and computer system validation (CSV) services, including the execution of forms and SOPs, for a Keyence and vision system upgrade project. Qualifications BS or higher in Chemistry/ Biology/ Microbiology/ Computer Science/ Information Systems/Engineering or related discipline. Background in pharmaceutical products manufacturing environment and in laboratories areas More than three (3) years of experience working with PLC’s, Industrial Computers with experience in commissioning and validating laboratory and manufacturing computerized systems in a manufacturing environment, and training in validation methodologies, technologies, and process control computer systems. Knowledge on computerized system with data collection software (database). Strong knowledge of cGMP, GAMP, SDLC, FDA, 21 CFR Part 11 and Data Integrity Regulations. Knowledge in MS Project Management and MS Visio programs. Experienced in Instrument Performance qualification, and method configuration Excellent skills writing commissioning/ validation, and technical documentation in English and using MS Office applications. Bilingual (both English/Spanish) Additional Information All your information will be kept confidential according to EEO guidelines.

Responsibilities

The CSV Specialist will provide commissioning, equipment qualification, and computer system validation services for a Keyence and vision system upgrade project. This includes executing forms and SOPs as part of the validation process.