We are searching Process Development Scientist with relevant experience in a commercial bio-pharmaceutical manufacturing environment, preferable supporting formulation and aseptic filling operations. Skills: Understanding of protein science, formulation and filling processes. Experience with process monitoring, data trending, and statistical analysis tools (e.g., JMP) Experience supporting deviations, investigations, root cause analysis, and product impact assessments. Requirements Doctorate or Master's Degree + 2 years of Scientific experience or Bachelor Degree +4 years of Scientific experience (Science or Engineering background) Ability to provide manufacturing floor support in a fast-paced, 24/7 operation. Bilingual proficiency in Spanish and English (written and verbal). Strong technical writing skills with experience preparing documentation for regulatory audits. Excellent communication, presentation, problem-solving, project management skills and cross-functional collaboration skills.
QRC group is a life science firm dedicated to provide services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
Our services and solutions include:
Process and Laboratory Investigation
• Corrective and Preventive Action (CAPA)
• Change Control
• Training
• Document Management Control
• QA Laboratory
• Methodology Transfer and Validation
• Instrument Calibration
• Validation and Training in Chromatographic Data Acquisition System
• Cleaning Validation
• Automation Engineering
• Quality Systems
