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QC Scientist

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Limerick
  • Sector: Science
  • Date posted: 01/08/2018
  • Job reference: BBBH14707

QC Scientist

Summary

Perform assay development, characterization, optimization, transfer, validation and investigation for QC chemistry group. Provide technical support, guidance and supervision for release, stability, and in-process testing and assay development.

Responsibilities

  • Performs assay development/validation for QC Chemistry or Biochemistry groups.
  • Reviews new test procedures and assays.
  • Evaluates and bring in new methodologies/techniques when needed
  • Facilitate assay transfer from R&D and to business partners.
  • Organize analytical assay transfer internally and externally
  • Lead technical troubleshooting and problem investigation.
  • Review analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance.
  • Participates in training programs for analysts.
  • Represent QC in project teams and provide Quality input across functional areas
  • Oversee Contract Laboratory testing
  • Position requires strong technical and troubleshooting skills in combination with strong communication skills in order to meet QC objectives
  • Requires approximately 30 to 40% of direct time in the laboratory
  • Write and review CMC sections for regulatory submissions

Experience/Education

  • Requires PhD in Biochemistry, Chemistry, Biology or related field, with 2+ years of relevant experience / MSc in Biochemistry, Chemistry, Biology or related field
  • 4+ years' relevant experience. Previous experience working in a GMP manufacturing environment is desirable.

Skills

  • Excellent Communication skills, both verbal & written.
  • Experience with electronic systems such as LIMS, SoftMax, Empower, Qumas, Trackwise etc., is an advantage.
  • Adaptable and flexible, willing to travel when needed.
  • Strong analytical ability and associated problem solving.
  • Good time management and attention to detail.
  • Knowledge and proficient in the use of Microsoft products including, Excel, Word and PowerPoint.

Interested?

Do not hesitate to reach out to Jack on 01-6455250 or email your CV to jack.conway-kenny AT experis.ie

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