QC Associate III

Fladger Associates

À propos

Fremont, CA
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

Avis aux utilisateurs

Cette offre a été publiée par l’un de nos partenaires. Vous pouvez consulter l’offre originale ici.