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.

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.