A Global Pharmaceutical Company located in Irvine is looking to identify and hire a Quality Assurance Technician II on a temp-to-hire basis. The Quality Assurance Technician II position supports the Quality Assurance Operation, which consists of QA Production Floor supports, and QA Product Release. This is a 2nd Shift position working 2:00pm-10:30pm, plus overtime.

The Quality Assurance Technician II will be responsible for, but not limited to:

• Providing Quality support to Manufacturing personnel for compounding and in-process checks.
• Performing line clearance verification, sterilization chart review, scale calibration verification, and QA in-process checks including but not limited to visual inspection, CISIT/PID test, weight check, and torque test.
• Preparing in-process samples for submission to the Quality Control Laboratory.
• Supporting handling of GMP events and initiation of deviation investigations.
• Reading, understanding, and following SOP’s and complying with cGMP.
• Supporting the issuance of GMP documentation to Manufacturing floor.
• Reviewing executed batch records for completeness, accuracy and compliance with Good Documentation Practices.
• Using computerized system such as SAP, LIMS, and TrackWise for data collection and batch record review.
• Scanning and filing batch records (physically & electronically).
• Performing other work-related duties as assigned by management.

Requirements:

• General high school degree/GED or equivalent required.
• Some college or technical college preferred.
• Prior experience working in Quality Assurance (QA) function preferred.
• Basic reading, writing, and math skills required.
• 1-2 years' experience working in a Pharmaceutical, Medical Device, or other FDA regulated industries required.
• Good computer skills.
• Strong attention to detail.
• Good verbal and written communication skills.
• Ability to work overtime and/or work occasionally on weekend as needed.