What are the responsibilities and job description for the LIMS Specialist position at Actalent?
Our client, a global CDMO in pharmaceutical manufacturing providing process development and cGMP production in cell culture, microbial fermentation and gene therapies, is looking for a Quality Control LIMS Specialist to support transitioning their labs from a paper documentation process to electronic lab notebooks.
The LIMS Developer is responsible for configuration, validation and ongoing maintenance within the LIMS platform. S/he will be expected to complete and review change requests, validate configurations, provide user support and troubleshoot as needed. S/he will be responsible to implement approved configuration changes within the LIMS platform as outlined in controlled change management records. The position will also be accountable to support documentation revisions in accordance with governing SOPs to ensure the system and procedures operate in a state of control. The ability to function in a fast-paced, highly technical environment, and communicate effectively is essential to success.
This position is responsible for ensuring that the LIMS system meets the requirements of the LIMS procedures. The LIMS Developer works closely with Quality Control, Analytical Development, Manufacturing and Quality Assurance to ensure compliance with GMP requirements.
- Work within the change management system to update configurations for specifications, analyses and other static data within the Laboratory Information Management System (LIMS), as needed.
- Provide timely response to end user needs to include troubleshooting applications, creating new configuration templates, and maintaining change records in accordance with version control procedures.
- Provide LIMS training, technical support, problem reporting and resolution(s) to Quality Control laboratory, QA, AD and Manufacturing staff
- Develop, implement, and maintain Standard Operating Procedures, Work Instructions and training materials for the LIMS.
- Evaluate data generated and/or stored within the System to provide ad hoc and long-term reporting solutions that address business needs and identify process gaps that might otherwise go unnoticed.
- Collaborate with the LIMS team, IT department, and LIMS users to ensure new functionality meets user requirements.
- Write test scripts for new LIMS functionality and participate in the validation of new functionality releases.
- Revise supporting documentation for LIMS: SOPS, Design Specifications, Work Instructions and training materials
- Support the expansion of the LIMS platform through the preparation and execution of test scripts for system validation.
- Liaison with end-users in the Laboratory to ensure changes to configurations meet the needs of the end user.
- Revise or develop LIMS functional requirement specifications and user requirement specifications as well as other relevant documentation with guidance.
Experience Level:
Intermediate Level
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Salary : $40 - $43
