QC Technical Resources Specialist

7 days ago

Nenagh, Ireland Regeneron Pharmaceuticals, Inc Full time

Within this role you will be part of the QC Technical Resources Material Identification Team and will be responsible for identifying unknown material observed at IOPS.

As a QC Technical Resources Specialist a typical day might include, but is not limited to, the following:

1. Driving investigation testing (FT-IR, SEM, ICP-MS, SEM, GC) for the chemical identification of unknown material for manufacturing, process sciences or quality control support
2. Evaluating/interpreting data, author and review technical documents for investigational testing
3. Establishing, developing and/or optimising analytical methodology for the analysis of unknown compounds/contaminates/debris in varying matrices
4. Participating in routine maintenance and troubleshooting of laboratory instrumentation
5. Liasing with contract laboratories as required to support investigational analysis
6. Tabulating results and writing summary reports of assay development and validation studies
7. Presenting findings at group and interdepartmental meetings
8. Producing and maintaining accurate records
9. Generating and/or supports completion of compliance records, CAPAs, change controls and deviation notifications as needed
10. Participating in technical troubleshooting and investigation
11. Supervising junior level group members, act as a mentor within the laboratory, including distributing work-load, monitoring progress and review/approve assigned work
12. Supporting and participate in regulatory inspections
13. Participating in cross-functional improvement initiatives/kaizens
14. Participating in developing, maintaining and presenting operational metrics

This role might be for you if:

1. You enjoy working in a fast-paced environment and you have the innate ability to balance multiple projects, prioritize them and complete them independently, while excelling at keeping all impacted parties well advised
2. You are able to work in a team environment but can also take ownership of large technical reports and projects
3. You can develop and drive scientific and/or business-related improvement ideas
4. You have working knowledge of Microsoft Suite (Word, Excel, Powerpoint, etc)
5. You understand working with statistical software such as JMP
6. You enjoy developing novel assays independently
7. You have development experience in identification-based analyses (e.g. FT-IR, SEM, ICP-MS, SEM, GC) in a GMP environment

To be considered for this opportunity you should hold BS/BA in a life sciences field and 2+ years of relevant experience in a cGMP environment or equivalent combination of education and experience.

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