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QC Chemist

Job description

What does this job involve?

  • The QC Chemist will be responsible for one or more of the following activities in QC including analytical testing, characterization, method development, sample and data management and equipment maintenance.
  • With a high degree of technical flexibility, work across diverse areas within the lab
  • Plan and perform routine analyses with efficiency and accuracy.
  • Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
  • Report, evaluate, back-up/archive, trend and approve analytical data.
  • Troubleshoot, solve problems and communicate with stakeholders.
  • Initiate and/or implement changes in controlled documents.
  • Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
  • Write protocols and perform assay validation and equipment qualification/ verification.
  • Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
  • Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.

 

What should you have?

  • Bachelor’s degree in a science discipline.
  • 3+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
  • Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning
  • Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
  • Project Management and organizational skills, including ability to follow assignments through to completion
  • Experience with regulatory compliance in GMP manufacturing and testing of pharmaceutical products.

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