Quality Technician II
- 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.
- 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.