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 Senior QC Scientist a typical day might include, but is not limited to, the following:
* Executing investigation testing (FT-IR, SEM, ICP-MS, GC) for the chemical identification of unknown material for manufacturing, process sciences or quality control support.
* Evaluating/interpreting data, authoring and reviewing technical documents for investigational testing.
* Establishing, developing and/or optimizing analytical methodology for the analysis of unknown compounds/contaminates/debris in varying matrices.
* Participating in routine maintenance and troubleshooting of laboratory instrumentation.
* Liaising with contract laboratories as required to support investigational analysis.
* Tabulating results and writing summary reports of assay development and validation studies.
* Presenting findings at group and interdepartmental meetings.
* Producing and maintaining accurate records.
* Generating and/or supporting completion of compliance records, CAPAs, change controls and deviation notifications as needed.
* Participating in technical troubleshooting and investigation.
* Supervising junior level group members, acting as a mentor within the laboratory, including distributing workload, monitoring progress and reviewing/approving assigned work.
* Supporting and participating in regulatory inspections.
* Participating in cross-functional improvement initiatives/kaizens.
* Participating in developing, maintaining and presenting operational metrics.
This role might be for you if you:
* Enjoy working in a fast-paced environment and have the innate ability to balance multiple projects, prioritize them and execute them independently, while excelling at keeping all impacted parties well advised.
* Can work in a team environment but also take ownership of large technical reports and projects.
* Can develop and drive scientific and/or business-related improvement ideas.
* Have working knowledge of Microsoft Suite (Word, Excel, PowerPoint, etc.).
* Understand working with statistical software such as JMP.
* Enjoy developing novel assays independently.
* Have development experience in identification-based analyses (e.g. FT-IR, SEM, ICP-MS, GC) in a GMP environment.
* Have excellent fine motor skills.
To be considered for this opportunity you should hold a PhD in Biochemistry, Chemistry, Biology or related field and 2+ years of experience, preferably in the pharmaceutical or biotechnology industries, or an MSc with 7+ years of experience in the same fields.
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