g process changes
• Support major/trend deviation investigations throughout the whole lifecycle including Root Cause Analysis investigation, determination of Corrective/Preventive Actions, authoring process investigation reports, and presenting within regulatory inspections.
• Support Risk Assessments exercises and Microbial assessment evaluations.
• Led commercial campaign readiness and effectively communicate and collaborate with cross function areas.
• Assist in the generation of training materials and assist in providing training on scientific or technical aspects of the process.
• Provide commercial support when needed and assist on the floor troubleshooting.
• Design, coordinate, and support execution of functional tests, water tests, and other runs to challenge process and operations during major changes, or campaign readiness. Generate technical protocols as needed.
• Assist and provide guidance during MBR (Master Batch Record) creation/revisions.
• Perform assessment to support process, automation, or equipment modification or implementation of special projects
• Initiate, revise, and approve standard manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
• Assess process performance and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
• Complete assessments for CAPA applicability requests from other plants/sites
• Complete assessment for new or changes in BOM's (Bill of Materials)
• Serves as a peer-recognized specialist in at least one area, with overall responsibility for determining methodologies in that area.
Requirements
Skills Required
- BS in Engineering
- In-depth experience of bio-processing unit operations
- Knowledge in Root Cause Analysis methodologies (Fishbone, Six Boxes, 5 Why's, Kepner Tregoe)
- Familiar with Lean Manufacturing Practices
- Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality
- Proficiency in GDP (Good Documentation Practices) in a regulated environment
- Knowledge in systems: Trackwise, Spotfire, CDOCS, and process monitoring platforms
- Strong technical writing and presentation abilities; excellent written/verbal communication skills in English and Spanish
- Willingness to work 8 hour shift Mon-Fri 8am-5pm with flexibility for on-call support
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.
