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QC Associate II

2 months ago

Fremont, United States IMS People Full time $30 - $35
Job DescriptionJob Description

Job Title: QC Associate II
Location: Fremont CA 94555
Duration: 06 Months
1st Shift: Monday-Friday: 9 AM to 6 PM

Job Description:
1st Shift: Monday-Friday: 9AM to 6PM Some overtime and weekends may be required as needed.

Duties:
Executes and coordinates routine and non routine testing in QC of bulk drug substance and drug product in a multi-product facility. 
Executes independently with adequate training fundamental operations such as biochemistry, drug product device testing, UV-vis absorbance, gel electrophoresis, pH, Osmolalilty Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.
Delivery of high quality analytical results within timeline right the first time Documents work according to cGMP and cGDP. Adheres to established regulations and follows cGMP established by site. 
Reports abnormalities and deviations in a timely and accurate manner. 
Adheres to safety standards and identifies unsafe situations / habits and escalates approriately. Maintains work production areas according to predefined standards (5s). Maintains own training within compliance and trains other technicians and associates on operations upon completion of trainer qualification. Represents QC operations on cross-functional root cause analysis teams for deviations, CAPAs and risk assessments

Skills:
3-5 years of industry experience GMP experience is highly prefered Demonstrates strong interpersonal and communication skills (both written and oral), a strong customer focus, and an ability to interact with various departments and levels. Demonstrates ability to work independently and as part of a team, to meet departmental/facility goals; is also able to work across functions to achieve common goals. Demonstrates strong attention to detail, and an ability to focus on details of Execution

Education: Bachelors' degree in Biology or Life Sciences required.