Sr. Associate PQA (24/7 Shift Role)

at  Amgen

BASIC QUALIFICATIONS & EXPERIENCE:

• University degree. Engineering or Science related discipline preferred.
• Relevant experience (4 years +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.

PREFERRED QUALIFICATIONS & EXPERIENCE:

• 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

KEY 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.