JT210 - MCS Manufacturing Sr. Associate

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:        

• Support manufacturing by providing subject-matter expertise for drug substance upstream and downstream processes as Single-use SME
• Lead sophisticated projects or parts of projects using project management skills.
• Resolve quick issues and execute function tests to troubleshoot and optimize process
• Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management.
• Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant.
• Support New Product introduction and projects through Single Use Systems (SUS) mapping
• Support manufacturing and quality through the SUS defect/leak triage process – perform troubleshooting on the floor, initiate investigation and bring leaks and defects to triage
• Initiate EN/SICAR records and follow process to conclusion, including working with vendors on investigation.
• Maintain up-to-date EN/SICAR/EE trackers and manage or lead small to medium projects
• Ability to successfully communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
• Ability to coach, mentor and/or cross train colleagues within core technical area.

• Bachelor's degree in engineering or Life Sciences
• 1 or 2 years of experience
• Project management
• Biotech manufacturing exposure
• Technical knowledge of drug substance processing and broad understanding of related disciplinary areas
• Experience leading and managing projects
• Understanding of Single Use Systems technologies
• Data analysis and/or data visualization skills
• Excellent writing skills. Presentation experience – presentation to leadership or auditors.
• Determines work tasks and timelines self-sufficiently – ability to navigate through ambiguity and prioritize effectively
• Proficiency in Smartsheet and excel, Trackwise, visio, pi, SAP, spotfire
• Onsite site M-F 7am-4pm
• Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule to execute function-testing and project tasks with minimal disruption to operations.

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.