INTAKE NOTES
* Assignment Duration: 6 months
* Shift Hours: 8:30-5pm
* Required Education: Requires a bachelor's degree in Engineering, Quality Assurance, or a related field
* Required # of years’ experience: 3-5
* Conversion possible for the right candidate
Manager Notes
* Supports Test Method Validation Remediation:
o Assists in the review and improvement of existing test method validation documentation
o Implements remediation plans to ensure test methods comply with current regulatory standards.
* Documentation and Compliance:
o Ensures validation documents meet FDA, ISO 13485, and other relevant regulatory requirements.
o Maintains accurate and organized records of validation activities.
* Qualifications:
o Requires a bachelor's degree in Engineering, Quality Assurance, or a related field.
o 3-5 years of experience in test method validation or a related area.
* Knowledge and Skills:
o Familiar with commonly used concepts, practices, and procedures in test method validation.
o Proficiency in technical writing and documentation.
* Work Guidelines:
o Relies on instructions and pre-established guidelines to perform job functions.
o Works under immediate supervision, with primary job functions not typically requiring independent judgment.
o Reports to a supervisor or manager.
Summary of Duties and Responsibilities
* Performs inspections and sets quality assurance testing models for analysis of raw materials, materials in process, and finished products.
* Requires a bachelor's degree and 0-2 years of experience in the field or in a related area.
* Has knowledge of commonly-used concepts, practices, and procedures within a particular field.
* Relies on instructions and pre-established guidelines to perform the functions of the job.
* Works under immediate supervision.
* Primary job functions do not typically require exercising independent judgment. Typically reports to a supervisor or manager.
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