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Quality Control Specialist

2 months ago

Fremont, California, United States eTeam Full time

Job Title: Quality Control Specialist

Location: eTeam

Duration: 6 Months

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

Key Responsibilities:

  • Execute and coordinate routine and non-routine testing in Quality Control of bulk drug substance and drug product in a multi-product facility.
  • Perform fundamental operations such as biochemistry, drug product device testing, UV-vis absorbance, gel electrophoresis, pH, Osmolality with minimal supervision.
  • Support internal operations including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.
  • Deliver high-quality analytical results within timelines, right the first time, and document work according to cGMP and cGDP.
  • Adhere to established regulations and follow cGMP guidelines set by the site.
  • Report abnormalities and deviations in a timely and accurate manner.
  • Adhere to safety standards and identify unsafe situations/habits and escalate appropriately. Maintain work production areas according to predefined standards (5S).
  • Maintain own training within compliance and train other technicians and associates on operations upon completion of trainer qualification.
  • Represent Quality Control operations on cross-functional root cause analysis teams for deviations, CAPAs, and risk assessments.

Requirements:

  • 3-5 years of industry experience
  • GMP experience is highly preferred
  • Demonstrate strong interpersonal and communication skills (both written and oral), a strong customer focus, and an ability to interact with various departments and levels.
  • Demonstrate 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.
  • Demonstrate strong attention to detail, and an ability to focus on details of execution.

Education: Bachelor's degree in Biology or Life Sciences required