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QA Technician Ii

5 months ago

Irvine, United States Siegfried Irvine Full time

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)

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