Location: Irvine
Type: Contract To Hire
Job #32573

Astrix Technology is seeking a QA Technician II- 2nd shift to join their team! This is a 4 month contract-to-hire position and will require the individual to perform their duties on-site.

Responsibilities

Raw Material Release
- Receive, collect and sample appropriate chemicals or components, and verify tests results for material release in accordance to raw material specification and applicable regulatory requirements or USP guidelines. When applicable, activities are to be performed in a controlled, clean room environment.
- Perform physical testing of various components using measurement instrumentation/tools as required.
- Revise and provide support in the development of Raw Material Specification and/or other controlled documentation including but not limited to Laboratory Test Submission (LTS) form and standard operating procedures.
- Support the routine cleaning activities of the clean room and support gowning areas.
In Process QA Support
- Provide in-process QA support for the manufacture of all products. These activities may include, however are not limited to weighing, compounding, line clearance, visual inspection, label verification, scribing and/or other various QA activities as required.
- Perform the QA testing on all saleable products according to applicable FDA, USP, NF, CFR and other standards.
- Perform validation testing to support the release of raw materials, in-process materials and finished product. Execute protocols to support the validation of new equipment and products.
Any and all other duties assigned by immediate supervisor.

Required Knowledge, Skills and Abilities

Training and knowledge in GMP/ISO 3-5 years for experience.
Basic computer knowledge and skills, Microsoft Office, Outlook
Experience using a database desirable
Strong attention to detail
Strong proofreading skills
Strong verbal and written communication skills
Strong organization skills

Required Education and Experience

High School Graduate or Associate Degree
3+ years’ experience is a QA/QC environment in Food & Beverage, Pharmaceutical, Medical Device or etc.

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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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Quality Technician II