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Quality Control Specialist

2 months ago

Fremont, California, United States System One Holdings, LLC Full time
Job Title: Quality Control Specialist

Job Summary:

System One Holdings, LLC is seeking a highly skilled Quality Control Specialist to join our team. As a Quality Control Specialist, you will be responsible for executing and coordinating routine and non-routine testing in QC of bulk drug substance and drug product in a multi-product facility.

Key Responsibilities:

  • Execute and coordinate routine and non-routine testing in QC of bulk drug substance and drug product in a multi-product facility.
  • Perform internal support duties 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 timeline right the first time.
  • Document work according to cGMP and cGDP.
  • Adhere to established regulations and follow cGMP established by 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 QC 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.

Benefits:

System One Holdings, LLC offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.