Regulatory Affairs Strategy Director
AstraZeneca · Juncos
CMCFull-timeCompany career page
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Role summary
Amgen seeks an Associate Manufacturing professional for night shift operations at its Puerto Rico facility. The role involves operating specialized biotech equipment, maintaining compliance with regulatory standards, and supporting 24/7 production of therapeutic medicines.
What they're looking for
- Bachelor's degree OR Associate's degree with 6+ months manufacturing experience OR High school/GED with 2+ years manufacturing experience
- Proficiency in operating specialized equipment per documented procedures
- Knowledge of Good Manufacturing Practices and GMP-regulated environments
- Strong attention to detail and documentation skills
- Computer literacy including MS Office and data entry systems
- Written and oral communication in English and Spanish preferred
- Intermediate mathematics and problem-solving abilities
What you'll be doing
- Operate bioreactors, autoclaves, buffer prep systems, and other specialized manufacturing equipment independently
- Monitor equipment, workspaces, and production outputs to ensure safety, quality, and regulatory compliance
- Record activities and verify production data accurately using electronic systems like SAP and batch records
- Identify equipment or process deviations and escalate issues per established protocols
- Collaborate with engineers, leads, and team members on troubleshooting and continuous improvement initiatives
Privacy & handoff
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