Within this role you will perform assay transfers, validation and investigation activities for QC. Provide technical support, guidance and supervision for release, stability, and in-process testing and assay development.
As a Senior QC Specialist a typical day might include, but is not limited to, the following:
* Performing assay validation for QC
* Reviewing new test procedures and assays
* Evaluating and bringing in new methodologies, techniques, and equipment as needed
* Generating and/or supporting the completion of compliance records, CAPAs, change controls and deviation notifications as needed
* Evaluating assay performance through yearly method performance reports
* Facilitating assay transfers from R&D and to business partners
* Organizing analytical assay transfer internally and externally
* Performing additional studies supporting regulatory filing e.g. Bridging/comparability studies
* Participating in technical troubleshooting and problem investigation
* Reviewing analytical development reports, assay and process validation reports and other technical documents for technical correctness and regulatory compliance
* Participating in training programs for analysts
* Supporting and participating in regulatory inspections
* Participating in cross-functional improvement initiatives/kaizens
This role might be for you if:
* 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
* You are able to work in a team environment but can also take ownership of large technical reports and projects
* You can develop and drive scientific and/or business-related improvement ideas
To be considered for this opportunity, candidates should hold a PhD in Microbiology, Chemistry, Biology, or a related field with 2+ years of experience, preferably in the pharmaceutical or biotechnology industries; an MSc with 7+ years of proven experience; or a BSc, which will be considered based on the candidate's years of experience and technical background, particularly within the pharmaceutical or biotechnology sectors.
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