Job Title: Laboratory Operations and Compliance Specialist
Job Summary:
This role will lead, coordinate, facilitate, and undertake activities related to lab operations and compliance with minimal supervision. The successful candidate will act as a role model for other lab colleagues, promoting a culture of continuous improvement and Right First Time (RFT) principles.
Key Responsibilities:
* Experience in various analytical techniques, including cell-based Bioassays, Immunoassays, Cell Culture, and Aseptic Technique. Familiarity with liquid-handling robots is an advantage.
* Plan, perform, and execute multiple complex routine/non-routine methods and procedures, as well as a wide variety of assays.
* Participate in the peer review of analytical data to ensure accuracy and quality.
* Provide technical guidance and apply expertise and critical thinking to resolve technical issues.
* Lead training sessions for staff on technical aspects of their jobs as required.
* Develop, revise, and implement procedures that comply with regulatory requirements.
* Qualify analytical equipment and conduct related testing functions.
* Participate in Analytical Method Transfers and ensure compliance with Standard Operating Procedures and Registered specifications.
* Maintain laboratory safety and ensure ongoing compliance to cGLP and cGMP regulations.
* Ensure timely completion of Laboratory Investigation Reports and deviations through Non-Conformance procedures.
* Contribute to the generation and update of SOPs, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications, and equipment qualifications.
* Participate in regulatory agency inspections as required.
* Develop and implement procedures and systems to maximize operating efficiency.
* Manage and contribute to department productivity and quality goals.
Requirements:
* Cell-based Bioassays, Immunoassays, Cell Culture (use of cells to execute bioassays), and Aseptic Technique experience are mandatory.