JT866 - 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 process owner (PPO) or Single-use SME
• Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management
• Own Quality Records, such as CCMS, CAPA, and CAPA-EV
• Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant
• Demonstrate strategic problem-solving skills and champion continual improvement
• Support operational readiness of new technologies, equipment, or processes by applying technical process, scientific, operational, and compliance knowledge with project management skills
• Develop/own drug substance manufacturing processes and procedures
• Draft and revise GMP manufacturing documents (SOPs, Forms). Draft and develop user requirements for new technologies

Qualifications:

• Bachelor’s degree in engineering or Life Sciences
• 3 years or more experience in Drug substance GMP technical support roles, GMP manufacturing, Engineering, Process Development, or equivalent
• Strong preference for those with upstream operations experience
• Comfortable working onsite Monday through Friday, with occasional flexibility for non-standard hours (including weekends) based on implementation needs
• While some remote administrative work (e.g., SOP revisions, tracker updates) may be allowed, onsite support is expected
• Familiarity with project management, as well as tools like Smartsheet and Excel, is highly desirable but not required
• Experience leading and managing projects
• Understanding of single-use technologies
• Data analysis and/or data visualization skills
• Excellent writing skills. Presentation experience – presentation to leadership or auditors
• Must be able to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance
• Standard shift (M-F 8am-5pm)
• 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