QC Associate III

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.
• Crosstrain in other RM duties to cover for other RM members when needed.
• Schedule: Monday to Friday 8:00am5:00PM
• In the beginning some flexibility to jump into a 2nd Shift or shift until midnight might be required for certain days during the month until team is fully crosstrained.

Experience:

• Bachelors Degree in a Scientific Discipline.
• 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 problemdetection and problemresolution 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 lowlevel work fine finger dexterity/ including grasping or pinching required
• Writing and use of a computer keyboard frequently
• Occasional use of personal protective equipment
• Required Skills: LIMS DOCUMENTATION ISO USP CGMP
• Additional Skills: MICROSOFT OFFICE LABORATORY TRACKWISE ICH CHANGE CONTROL SOPS TEST PLANS SAMPLING ANSI ASQ