Job Summary:
* We are seeking a Senior Quality Control Scientist to join our team.
* This role will be responsible for performing assay transfers, validations and investigations.
* The successful candidate will provide technical support and guidance for release, stability and in-process testing and assay development.
* Evaluation of new methodologies, techniques and equipment is also required.
* Compliance records, CAPAs, change controls and deviation notifications need to be generated or supported as needed.
* Annual method performance reports require evaluation of assay performance.
* Assay transfers from R&D and to business partners will be facilitated.
* Internal and external analytical assay transfers will be organized.
* Studies supporting regulatory filing, including bridging/comparability studies, will be performed.
* Technical troubleshooting and problem investigation will be participated in.
* Review of analytical development report, assay and process validation report and other technical documents will be conducted.
* Training programs for analysts will be participated in.
* Support and participation in regulatory inspections will be provided.
* Cross-functional improvement initiatives/kaizens will be participated in.
Requirements:
* Bachelor's or Master's degree in Biochemistry, Chemistry, Biology or related field is required.
* 0-2 years of experience preferably in the pharmaceutical or biotechnology industries or MSc with 4+ years of experience preferably in the pharmaceutical or biotechnology industries is expected.
* Working knowledge of Microsoft Suite (Word, Excel, Powerpoint, etc) is necessary.
* Understanding of working with statistical software such as JMP is required.