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Job Description
Overview:
The Plant Quality Assurance (QA) Senior Associate will report to a Senior QA Manager and is a core member of the site QA team.
Medical Device assembly Serialized Packaging and labelling
Role Responsibilities:
- Analise and ensure quality oversight and support for manufacturing on the floor at all times.
- Perform manual pack check and deft assessment
- Complete all activities in compliance with all safety standards and standard operating procedures.
- Perform Batch Review to support customer complaint investigations
- Provide quality support for triage and investigation of all classes of deviation events.
- Perform purposeful presence on the floor audits.
- 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
Minimum Qualification :
Science Degree /Engineering degree
Preferred Traits/Characteristics:
- Strong attention to detail in terms of task execution and QA review.
- Proven in Risk Based Decision Making ability to assess both the impact of an event that occurs and the suggested pathforward.
- Excellent written and verbal communication skills ability to communicate across different teams/backgrounds & up/down different levels with the organization.
- Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
- Ability to do shift role 24/5 (at the moment shift schedule can change according to business needs, notice will of course be provided of ant change to cycle)
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.