SR. ASSOCIATE – Amgen Careers West Palm Beach

Position Title: SR. ASSOCIATE

Company: Amgen

Location: West Palm Beach, FL, USA

Job Description:

If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.

Responsibilities:

• Perform all activities in compliance with Amgen safety standards and standard operating procedures.
• Observe and provide real-time quality oversight and support for manufacturing on the floor.
• Perform purposeful presence on the floor audits.
• Perform manual visual inspection AQL audits of vials and syringes.
• Perform QA reserve sample inspections as part of the annual reserve inspection program and in support of customer complaint investigations
• Certification of defect panels.
• Provide quality support for triage and investigation of all classes of deviation events.
• Review/approve deviations for closure ensuring compliance with appropriate standards.
• Review/approve production batch records, and associated documentation in preparation for qualified person disposition activities.
• Provides training and advice to staff in order for them to perform their desired functions.
• Write, review and approve standard operating procedures in accordance with Amgen policies.
• Support continuous improvement and operational excellence initiatives
• Any other tasks/projects assigned as per manager’s request.

Requirements:

• Excellent written and verbal communication skills
• Experience working with dynamic cross-functional teams and proven abilities in decision making
• Strong organizational skills, including ability to follow assignments through to completion
• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations
• Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
• Operational Excellence experience