Senior Quality Control Specialist
4 days ago
We are seeking a highly skilled Senior Quality Control Specialist to join our team. In this role, you will be responsible for performing assay transfers, validation, and investigation activities for QC.
As a Senior Quality Control Specialist, your typical day might include:
- Performing assay validation for QC
- Reviewing new test procedures and assays
- Evaluating and implementing new methodologies, techniques, and equipment as needed
You will also have the opportunity to generate and/or support compliance records, CAPAs, change controls, and deviation notifications as required.
In addition, you will evaluate assay performance through yearly method performance reports, facilitate assay transfers from R&D and to business partners, and perform additional studies supporting regulatory filing.
Key Responsibilities- Perform assay validation for QC
- Develop and implement new methodologies, techniques, and equipment as needed
- Generate and/or support compliance records, CAPAs, change controls, and deviation notifications as required
- Evaluate assay performance through yearly method performance reports
- Facilitate assay transfers from R&D and to business partners
- Perform additional studies supporting regulatory filing
- PhD in Microbiology, Chemistry, Biology, or a related field with 2+ years of experience, preferably in the pharmaceutical or biotechnology industries
- MSc with 7+ years of proven experience; or BSc with relevant technical background
- Strong analytical and problem-solving skills
- Excellent communication and interpersonal skills
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