QC Analyst II

Posted 3 Days Ago
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Stein, Aargau
Mid level
Biotech • Pharmaceutical
The Role
The QC Analyst II will perform analytical testing and documentation of drug and packaging materials per GxP standards, manage samples, report complaints, and ensure readiness for inspections, following SOPs and optimizing processes for efficiency.
Summary Generated by Built In

Job Description Summary

-This role utilizes biological laboratory skills to test and measure product or materials while ensuring that analysis is performed according to established Standard Operating Procedures (SOPs), Analytical Methods & current Compendia.


 

Job Description

Major accountabilities:

  • Sample storage and management -Analytical testing/documentation of drug product / finished product / complaints / stability / packaging material samples to GxP standards Stability -Testing/Sample storage and management .
  • Analytical documentation of stability samples to GxP standards -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

  • Orders are processed correctly and quickly.
  • No waiting times due to wrong or delayed order.
  • Deadline adherence rate: orders completed on time, all missed deadlines reported in good time, the shortest possible lead time -Ensure constant readiness for inspection, no critical complaints from superiors and inspectors -Consistently follow the GMP and GSU guidelines, as well as the SOPs, no critical irregularities -Finding and implementing optimization options to reduce costs -Completed training plan

Minimum Requirements:
Work Experience:

  • Sound technical & scientific knowledge of pharmaceutical/ chemical.
  • Working experience in Laboratory environment in the Pharmaceutical.
  • analytics/QC/ equivalent.
  • industry.

Skills:

  • Continuous Learning.
  • Dealing With Ambiguity.
  • Decision Making Skills.
  • Gxp.
  • Industry Standards.
  • Laboratory Equipment.
  • Laboratory Excellence.
  • Quality Control (Qc) Testing.
  • Quality Control Sampling.
  • Self Awareness.
  • Technological Expertise.
  • Total Quality Management.

Languages :

  • English.


 

Skills Desired

Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Laboratory Equipment, Laboratory Excellence, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Technological Expertise, Total Quality Management

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The Company
HQ: Basel
110,000 Employees
Hybrid Workplace
Year Founded: 1996

What We Do

Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.

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