QC Scientist – Limerick

  • Reference: GY47019
  • Job Type: Permanent
  • Location: Limerick
  • Category: Science, Pharmaceutical & Food

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. 

Essential Duties and Responsibilities include, but are not limited to, the following:
• 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

 

Education:
• Requires PhD in Biochemistry, Chemistry, Biology or related field, with 2+ years of relevant experience / MSc in Biochemistry, Chemistry, Biology or related field with 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.
• Collaboration and team work. Maintains the highest standards of ethical behaviour.
• Results and performance driven.
• 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.

For a confidential discussion and more information on the role/company please  email your CV to: amy.oneill@collinsmcnicholas.ie


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Amy O’Neill

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  • Amy O’Neill
  • Recruitment Consultant
  • 091706718
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