QA Technician Ii - Irvine, United States - Siegfried Irvine
Description
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._
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Responsibilities_
- Provide Quality support to Manufacturing personnel for compounding and inprocess checks.
- Perform line clearance verification, sterilization chart review, scale calibration verification, and QA inprocess checks including but not limited to visual inspection, CISIT/PID test, weight check, and torque test.
- Prepare inprocess 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 workrelated 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.
- 12 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:
$ $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:
- Inperson
- Manufacturing facility
- Office
Education:
- Bachelor's (preferred)
Experience:
- Pharmaceutical or
Shift availability:
- Overnight Shift (required)
Ability to Commute:
- Irvine, CA required)
Work Location:
In person
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