QC Associate IV

Responsibilities:

• Excellent employment opportunity for a QC Associate IV in the Fremont, CA area.
• Reviews raw material lot packages and releases RM lots for GMP manufacturing use.
• Ensures lot release timelines will be met and coordinates testing performed at in-house and contract laboratories.
• 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.
• 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.
• Interacts with functional groups within and outside of QC and recognition of issues that require elevation to upper management.
• 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.)
• Performs logbook and/or LIMS entries when using equipment/instruments.
• Reconciles samples.
• Perform weekly and monthly reviews of appropriate forms (e.g., test records) and logbooks.
• Assists with QC's data management, including data review and trending.
• Maintains specific QC files and database records for process and/or quality improvement efforts.
• Maintain laboratory cleanliness and orderliness.
• Cross-train in other RM duties to cover for other RM members when needed.

Experience:

• Bachelors' Degree
• 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
• 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
• Occasional use of personal protective equipment
• Required Skills: LIMS, DATABASES, TRACKWISE, SOP, GMP,
• Additional Skills: ICH/GCP, MICROSOFT OFFICE, ANSI, CHANGE PROCESS MANAGEMENT, CHARTING, DATA MANAGEMENT, RECONCILIATION, SAMPLING