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hace 2 meses
The Quality Assurance Specialist II is responsible for ensuring quality compliance in all aspects of production operations. This role involves providing quality assurance knowledge and hands-on support, ensuring that all site operations remain compliant with FDA regulations, ISO standards, customer requirements, and internal policies and procedures.
Key Responsibilities:- Quality planning, validations, FMEA and risk analysis, capability studies, and variance management
- Developing, reviewing, and revising procedures, complaint investigation and resolution, and RCA analysis
- Providing Quality representation and support in quality assurance testing methodology, internal and external audits, vendor qualifications, and training initiatives
- Ensuring all personnel comply with FDA regulations, ISO standards, customer requirements, and SOPs
- Representing Quality in signing on Change Orders and managing all Quality responsibilities for assigned manufacturing changes
The Quality Assurance Specialist II will also participate in validation activities, including draft and/or review protocols and reports, and qualify/validate production processes for installation qualifications (IQ), operational qualifications (OQ), and performance qualifications (PQ).
