Quality Engineer

Company : Elite Protek

Job Type : Full Time

Oceanside, United States

Job Description - Quality Engineer

Qualifications:

Bachelor of Science Degree
2 years of GMP experience and knowledge about GMP QE
Support Commissioning, Qualification, and Validation activities
Maintain Process/Equipment reliability programs including a Total Preventive Maintenance
Experience with federal regulations regarding GLP and GMP
Experience with gathering pertinent data, preparing narrative reports, statistical reports, charts, graphs, and tables
Knowledge of FDA Good Laboratory Practice, Good Tissue Practice and Good Manufacturing Practice guidelines
Demonstrated ability to develop and monitor quality improvement plans and SOPs

Responsibilities:

Responsible for supervising other QA officers providing training and guidance in day-to-day Good Manufacturing Practices (GMP) compliance activities
Responsible for training and providing guidance to other staff and facility users/clients
Expected to report regularly and provide updates to Quality management
80% - Responsible for day-to-day QE activities including support of OOS, deviations, CAPA and change control documents, and Quality Engineering support of production activities
Responsible for writing, review, and approval of technical assessment of Master Production (batch) Records, Standard Operating Procedures (SOPs), worksheets, forms, Specifications, Validation Protocols and reports, and Production Record Control systems to ensure compliance

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Quality Engineer

Job Description - Quality Engineer

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