Jt- Mcs Manufacturing Associate

Overview

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.

• Perform auxiliary tasks as needed (Batch Record Review, Closing Deviations, Document Revisions, Protein Concentration Testing).
• Prepare buffers and media per Manufacturing Procedures (MPs) and SOPs
• Follow GMP documentation (SOPs, MPs) with strict adherence to safety and compliance
• Perform and monitor critical processes, including basic troubleshooting
• Conduct in-process sampling and operate analytical equipment
• Execute washroom activities, including cleaning small and large-scale production equipment
• Maintain an organized and clean workspace
• Work in a clean-room environment while wearing steel-toe shoes, full gowning, hairnet, and gloves
• Assist in reviewing documentation such as equipment logs and batch records
• Identify, recommend, and implement improvements related to routine functions
• Perform operations in the Manufacturing area, specifically for Purification processes.

• Bachelor’s degree or associate degree in related area
• 4 years of Manufacturing experience
• Knowledge of large-scale biotechnology operations such as purification, cell culture, aseptic processing, etc.
• Prior manufacturing experience, basic AI knowledge, MS O365 knowledge
• Knowledge of Single-use-Systems
• CFR and Regulatory knowledge
• Ability to interpret and apply GMP knowledge
• Basic troubleshooting skills on production equipment
• Experience with Delta V
• Experience with lab equipment/testing
• Shift: 6:30 AM - 7:30 PM - Wednesdays - Saturdays week 1 of rotation (Thursdays - Saturdays week
  2)
• Switches to graves every 6 months on rotation.
• Candidates will start working day shift for the first 4-5 months and rotate with the team.

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.