Job Summary
This role will lead, coordinate, facilitate and undertake activities related to lab operations and compliance with minimal supervision, serving as a model for other lab colleagues.
Key Responsibilities:
* Experience in various analytical techniques including cell-based bioassays, immunoassays, cell culture and aseptic technique is required. Knowledge of liquid-handling robots is also beneficial.
* The role involves planning and performing multiple complex methods and procedures, as well as participating in the peer review of analytical data.
* Technical guidance will be provided and critical thinking applied to resolve technical issues. Staff training on technical aspects of the job will also be led as required.
* Procedures will be developed, revised and implemented to comply with regulatory requirements.
* Qualification of analytical equipment and related testing functions is necessary.
* The role requires participation in analytical method transfers and adherence to Standard Operating Procedures and registered specifications.
* A safe working environment in the laboratory must be ensured.
* Maintaining quality systems within the QC laboratories to ensure ongoing compliance with cGLP and cGMP is crucial.
* Timely completion of Laboratory Investigation Reports and deviations through Non-Conformance procedures is essential.
* Participation in the generation and update of SOPs, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications is required.
* Regulatory agency inspections may require participation.
* Procedures and systems should be planned and implemented to maximize operating efficiency.
* Department productivity and quality goals should be managed and contributed to.