The Quality Assurance Technician III supports the Quality Assurance Operation, which consists of QA Production Floor supports, and QA Product Release.

This is a 3rd Shift position.

Responsibilities

• Provide Quality support to Manufacturing personnel for compounding and in-process checks.
• Perform 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.
• Prepare in-process samples for submission to the Quality Control Laboratory.
• Support handling of GMP events and initiation of deviation investigations.
• Read, understand, and follow SOP’s and complies with cGMP.
• Support the issuance of GMP documentation to Manufacturing floor.
• Review executed batch records for completeness, accuracy and compliance with Good Documentation Practices.
• Use computerized system such as SAP, LIMS, and TrackWise for data collection and batch record review.
• Scan and file batch records (physically & electronically).
• Perform other work-related duties as assigned by management.

Required Knowledge, Skills and Abilities

• Good computer skills
• Strong attention to detail
• Good oral and written communication skills
• Ability to work overtime and/or work occasionally on weekend as needed

Required Education and Experience

• High School Diploma or equivalent required.
• Some college or technical college preferred.
• Prior experience working in 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.

Pay Range: $23-25/hour 15% Differential for working on 3rd Shift (10 PM - 6:30 AM)

Job Type: Full-time

Pay: $23.00 - $25.00 per hour

Expected hours: No less than 40 per week

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Experience level:

• 1 year
• 2 years

Schedule:

• Monday to Friday
• Night shift
• Overtime
• Weekends as needed

Work setting:

• In-person
• Manufacturing facility
• Office

Education:

• Bachelor's (Preferred)

Experience:

• Pharmaceutical or Medical Device: 1 year (Required)

Shift availability:

• Overnight Shift (Required)

Ability to Commute:

• Irvine, CA 92618 (Required)

Work Location: In person