Kelly Services QC Associate II: HPLC/CE in Fremont, California
QC Associate II: HPLC/CE
Kelly Scientific is currently seeking a Quality Control Associate II with experience in HPLC and capillary electrophoresis to work for one of our top clients in Fremont, CA.
Shift: Swing or Night Shift (may need to support weekend activities)
Executes and coordinates routine and non-routine testing operations in QC of bulk drug substance and drug product in a multi-product facility. Performs duties under limited supervision and according to standard operating QC procedures.
Executes independently with adequate training fundamental operations such as HPLC and Capillary electrophoresis.
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 appropriately. Maintains work production areas according to predefined standard (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, CAPA and risk assessments.
Education and Experience
Bachelors’ degree in Life Sciences required.
3-5 years of industry experience.
GMP experience is highly preferred.
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.
Demonstrates strong attention to detail, and an ability to focus on details of execution.