Kelly Services QC Associate II: HPLC/CE in Fremont, California

QC Associate II: HPLC/CE

Fremont, CA

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)

1-year contract

Job Duties:

  • 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.

Qualifications:

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.