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JT866 - MANUFACTURING SR. ASSOCIATE

Quality Consulting Group, LLC
Thousand Oaks, CA Temporary
POSTED ON 4/1/2025
AVAILABLE BEFORE 9/27/2025

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

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