TEMP Manufacturing Tech I, San Clemente

Title: Manufacturing Technician Location: San Clemente, CA Duration: Temp to Hire

1st shift: 6:00AM - 2:30PM 2nd Shift: 2:30PM - 11:00PM

Position Overview (An Overview of the Department&Summary of the Role) You will be responsible for the following:

Perform kitting operations (measure out components or raw materials) Ability to perform activities under a microscope Prepare components and build device assemblies Prepare bulk drug formulations Perform filing, capping, and crimping operations Perform packaging and labeling operations Perform samplingPerform visual inspections Perform documentation and data input into materials requirement planning (MRP), Batch Records (BRs), and Device History Record (DHR) Perform all activities with good documentation practices (GDP) in accordance with current good manufacturing practices (cGMPs) and quality management system (QMS) medical device good manufacturing practices (GMP) requirements.Additional tasks as required RESPONSIBILITIES: (Essential Functions and Associated Tasks for the Role)

Maintain proper cleanroom environment (including gowning, room cleaning, and supplies) Follow, execute, and adhere to documentation in accordance with cGMP, QMS, and GDP requirements: protocols, specifications, work instructions (WIs), standard operating procedures (SOPs), batch records (BRs), device history records (DHRs), and engineering batches.Perform basic calculation and data entry Ability to assemble, disassemble, and clean process equipment Ability to clean, etch, passivate, assemble, and inspect components Process and assemble components in accordance with documented specifications and procedures Prepare bulk drug formulation operationsPerform filling, capping and crimping operations Perform packaging and labeling operations Perform in-process inspection of assemblies and finished products in accordance with specification criteria Organize and clean the work areas Ability to perform validation and qualification activities (IQ/OQ/PQ/PV)WORK EXPERIENCE: (Provide Experience, Knowledge, Skills&Abilities Required for the Role)

0 - 2 years of related experience in the medical device, pharmaceutical, and/or biotechnology industries It is highly desirable to have experience working in and maintaining a cleanroom in accordance with GDP and cGMPs standards.

EDUCATION: High School Diploma Required

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