QC Associate III - eTeam Inc.
Fremont, CA 94555
About the Job
Job Title: QC Associate III
Location: Fremont, CA 94555
Duration: 24+ Months Contract
Duties:
Location: Fremont, CA 94555
Duration: 24+ Months Contract
Duties:
- Performs tasks and activities related to supplier/material qualifications and supplier change notifications (e.g., review of vendor documentation, review of vendor and material history, etc.)
- Review, author, and edit documents, including deviations, change control requests, SOPs, test methods, material specifications, analytical investigations, and laboratory test plans and related technical reports.
- Ensure compliance with current regulations.
- Supports lot release activities.
- This includes, but not limited to, preparation of sample submission forms, performing necessary LIMS and SAP transactions, review of test records, tracking status of samples and their respective tests, etc.
- Interacts with functional groups within and outside of QC and recognition of issues that require elevation to upper management.
- Maintain laboratory cleanliness and orderliness.
- Cross-train in other RM duties to cover for other RM members when needed.
- In depth experience in a laboratory environment - Six (6) years cGMP or appropriate experience required.
- Knowledge of ANSI/ASQ Z1.4, DIN ISO 2859 or other sampling standards required.
- Strong technical writing required.
- Knowledge of CFR, USP, and ICH required.
- Knowledge of SAP, Trackwise and LIMS desired.
- Working knowledge of Microsoft Office systems, LIMS, lab instrumentation and other relevant systems.
- Highly productive, attention to detail, ability to manage time and prioritize tasks with input from manager to meet timelines.
- Demonstrated problem-detection and problem-resolution skills required.
- Lifting, carrying, pushing or pulling up to 50 pounds occasionally.
- Frequent periods of sitting, walking, and standing.
- Occasionally must climb stairs or ladders, balance, bend or stoop, crouch or squat.
- Occasional low level work, fine finger dexterity/ including grasping or pinching required.
- Writing and use of a computer keyboard frequently.
- Occasional use of personal protective equipment.
Source : eTeam Inc.