QC Associate III
Fladger Associates
- Fremont, California, United States
- Fremont, California, United States
Über
Contract Duration: 5-24 months
Rate: Negotiable
Salary: NA $1.00
Responsibilities:
- Excellent employment opportunity for a QC Associate III in the Fremont, CA area.
- 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.
Experience:
- Bachelors' Degree in a Scientific Discipline. Six (6) years cGMP or appropriate experience required.
- In depth experience in a laboratory environment
- 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
- Physical Demands / Surroundings: 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
Sprachkenntnisse
- English
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