Remote Specialist Manufacturing

Summary

Join our team! PharmaLex is a highly successful and growing consulting company for the Healthcare industry around the world. We are committed to providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.

Requirements

• Doctorate degree OR Master's degree and 3 years of Manufacturing Operations experience OR Bachelor's degree and 5 years of Manufacturing Operations experience or Associate degree and 10 years of Manufacturing Operations experience or High school diploma / GED and 12 years of Manufacturing Operations experience
• Background in Quality or Engineer
• Project Management skills and experience. Demonstrated ability to coordinate and effectively participate in cross-functional project teams and deliver on schedule
• Detailed technical understanding of bioprocessing unit operations
• Skilled in performance of GMP production operations
• Regulatory knowledge and interactions
• Participate and help lead cross-functional teams
• Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality
• Organizational, technical writing and presentation skills
• Basic project management skills
• Basic knowledge of control charting

Responsibilities

• Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner
• Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities
• Provide troubleshooting support
• Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process
• Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations
• Ensure that all Non-conformances are triaged within the established goal
• Responsible for authoring investigation reports
• Responsible for execution of corrective actions
• Responsible for managing NC/CAPA closure within established goal
• Monitor and communicate incidents trends
• Review equipment/system Root Cause Analysis investigations and support trend evaluations
• Assist with generation of process validation protocols and reports
• Assist with the execution of the process validation
• Support collection and analysis of process validation data
• May participate in regulatory inspections
• Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications
• Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects
• Assist manufacturing change owner on CCRB packages impacting the process
• Participate on the assessment or implementation of special projects or initiatives