The Role
Perform validations and commissioning/qualification of manufacturing and laboratory equipment (IOQ, PQ, functional testing). Author and review technical documents and reports, manage quality systems (deviations, change control), support maintenance processes (PM, work orders, job plans), and review/approve process and cleaning validation documentation. Requires technical writing and bilingual Spanish/English capability.
Summary Generated by Built In
We are seeking Quality Professional with Validations and Commissioning & Qualifications of manufacturing equipment and laboratory bench equipment experience (IOQ, PQ, Functional Test). In addition to Technical Writing, Quality Systems (Deviations, Change Control) and Maintenance (PM, Work Orders, Job Plans review and approval) knowledge. Technical Documents review and approval (Reports, Technical reports, Procedures, Forms) of process and cleaning validation.
The candidate for this position is required to be available to work both on-site and remotely.
Requirements
- Doctorate or Masters + 2 years of directly related experience or
Bachelors + 4 years of directly related experience or
Associates + 8 years of directly related experience - Bilingual (Spanish/English)
- Technical Writing
Skills Required
- Doctorate or Masters + 2 years OR Bachelors + 4 years OR Associates + 8 years of directly related experience
- Bilingual Spanish/English
- Experience with validations and commissioning and qualification of manufacturing and laboratory equipment (IOQ, PQ, Functional Test)
- Technical writing
- Knowledge of Quality Systems (Deviations, Change Control)
- Maintenance knowledge (PM, Work Orders, Job Plans review and approval)
- Technical document review and approval (reports, procedures, forms) for process and cleaning validation
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The Company
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
