Senior Bioanalytical Associate
This role involves implementing continuous improvement projects and fostering a culture of excellence.
The successful candidate will be responsible for representing the QC unit, liaising with internal and external customers, and leading training sessions on technical aspects of the job as required.
Duties include:
* Experience in analytical techniques such as cell-based bioassays, immunoassays, cell culture, and aseptic technique.
* Plan and perform routine and non-routine methods and procedures.
* Participate in peer review of analytical data.
* Provide technical guidance and critical thinking to resolve technical issues.
* Lead staff training on technical aspects of the job.
* Develop, revise, and implement procedures that comply with regulatory requirements.
* Qualify analytical equipment and related testing functions.
* Participate in analytical method transfers.
* Ensure laboratory operations are conducted safely.
* Maintain quality systems within the QC laboratories.
* Timely completion of Laboratory Investigation Reports and deviations through Non-Conformance procedures.
* Participate in generation and update of SOP's, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications, and equipment qualifications.
* Participate in regulatory agency inspections.
* Plan and implement procedures to maximize operating efficiency.
* Manage and contribute to department productivity and quality goals.
Requirements:
* Bachelor's degree in Science - Biochemistry or Biology.
* Cell-based testing experience in bioassays, immunoassays, cell culture, and aseptic technique.
* GMP experience.
* Biochemistry experience.