Fremont CA
Contract Duration: 3036 months
Rate: Negotiable
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