Quality Engineer

Job Description :

Pay Range : $24hr - $25hr

Responsibilities :

• Collects current equipment documentation to fill gaps or identify missing information.
• Working with Validation Engineers and quality assurance document control to implement necessary improvements.
• These may include modifications to existing documents, or collection and filing of current documents.
• Supports validation protocols for data collection, or creating documents, as assigned.
• Maintains compliance with regulatory agency guidance and client procedures.
• Assists with execution of equipment validation studies to include protocol execution, data analysis up to including control system administration such as software backups and system updates.
• Programs and operates department analytical instruments (such as temperature / humidity dataloggers) to perform controlled temperature / humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.).
• Drafts commissioning and qualification protocols to sufficiently demonstrate the process is designed and fit for the intended use.
• Supports on-going system requalification and continuous improvement activities governed by change management processes.

Skills :

Education / Experience :