Biopharmaceutical Production Specialist

1 week ago


Newbury Park, California, United States Actalent Full time
Job Summary

The Associate of Manufacturing will work in a dynamic production environment at Actalent, supporting development, clinical, and launch activities. Under general supervision, the employee will perform operations in the Manufacturing area. Operations will be performed according to Standard Operating Procedures (SOPs).

Key Responsibilities
  • Hands-on Operations: Set-up, cleaning, and sanitization of various manufacturing equipment
  • Quality Control: 100% manual inspection per defined manufacturing procedures (MPs) and standard operating procedures (SOPs)
  • Testing and Analysis: Testing of drug product in-process/release samples per defined methods and SOPs
  • Compliance and Safety: Following GMP documents (SOPs, MPs) with strict adherence to safety and compliance
  • Process Monitoring: Performing and monitoring critical processes with the ability to perform basic troubleshooting
  • Equipment Maintenance: Performing in-process sampling of equipment and operating analytical equipment
  • Quality Assurance: Performing inspection activities of filled containers
  • Work Environment: Maintaining an organized and clean workspace
  • Personal Protective Equipment: Working in a GMP room environment, full clean room gowning, hairnet, and gloves when performing all work
  • Documentation: Initiating quality reports
  • Process Improvement: Drafting and revising documents (SOPs, MPs)
  • Continuous Improvement: Identifying, recommending, and implementing improvements related to routine functions
  • Review and Approval: Assisting in the review of documentation for assigned functions (equipment logs, batch records)
  • Physical Demands: Performing activities that include periods of rigorous, repetitive work
  • Work Environment: Working around high-pressure systems and occasionally working around heavy equipment
Requirements
  • B.S. in Life Sciences Discipline
  • Interest in biotech industry
  • Flexibility to work 1st, 2nd, or 3rd shift
What's in it for you?
  • Gain experience in a manufacturing environment
  • Make an impact in patients' lives
  • Competitive pay


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