CSV Specialist 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

Tech Transfer, Process Design, Commissioning & Qualification, Vision System Technologies, Inspection/Packaging Concepts, Data Analysis, Testing Strategies, Technical Reports Development, Validations, cGMP, GAMP, FDA, Data Integrity Regulations, Automation Process, Statistics, MS Project Management, MS Vision

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 with experience in Bioprocess Validations. Technical Skills: Tech Transfer, Process Design, Commissioning & Qualification. Vision system technologies (Strong). Inspection/packaging Concepts. Development and Execution of Processes/Equipment Characterization Duties: Provides data analysis/interpretation and assesses the impact of the data on the project. Establish Testing Strategies. Technical Reports Development. Validations, and technical reports- To support SATs executions, document generation and challenge validations strategies. Qualifications BS or higher in Chemistry/ Biology/ Microbiology/ Computer Science/ Information Systems/Engineering or related discipline. Background in pharmaceutical products manufacturing environment and in manufacturing and laboratories areas More than five (5) years of experience working with process validation life cycle, 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, SAT, FDA, 21 CFR Part 11 and Data Integrity Regulations. Experience in Automation process and/or Vision Inspection systems development. Knowledge in statistics using Mini-tab, JMP or other statistical software, project management skills and knowledge in development documentation protocols and reports. Knowledge in MS Project Management and MS Vision programs. Advanced scientific analysis and troubleshooting skills. 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 data analysis and interpretation, assessing the impact of data on projects. They will establish testing strategies and develop technical reports to support validations and document generation.