Job Description
As a QC Operations Scientist, you will be responsible for carrying out tasks and supporting projects relating to QC LIMS computer systems as LIMS administrator, sample management, and general QC-compliance functions while ensuring the highest standards of Good Laboratory Practices, regulatory requirements and quality within the business is adhered to.
Duties and Responsibilities
* Ensure the tasks associated with the startup and routine operations of a QC Operations laboratory are carried out in a safe manner.
* Support QC Operations as Lab administrator for LIMS system i.e. complete LIMS configuration builds on storage locations, stability protocols, stock builds etc.
* Support QC Operations lab set-up, including laboratory design, equipment installation and qualification utilizing principles of Operational Excellence and Lean Labs.
* Support facility qualification, process validation, etc.
* Develop and maintain quality systems within the QC Operations Laboratory to ensure compliance to cGLP.
* Aiding in the identification and development of Contract Test laboratories and strategies.
* Development of training material for the QC Operations Laboratory personnel in particular training to LIM administrators and LIMS users.
* Perform additional duties at the request of the direct manager.
* Support QC Senior scientist in OOS, OOL, adverse trends, any excursion investigations, change controls, and CAPAs tasks.
* Author technical documents including methods protocols, qualification/validation protocols and reports, SOPs, etc.
* Support Risk Assessments for projects and business innovation initiatives from a QC Operational perspective.
* Keep abreast of current corporate and regulatory trends and requirements pertaining to laboratory operations.
Requirements
* Knowledge of LIMS System as administrator or completing LIMS configuration changes i.e. performing stock builds/stability build
* Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals; ICH and GMP guidelines desirable.
* Experience with regulatory/customer audits is desirable.
* Experience in a large-scale Biopharmaceutical/pharmaceutical facility.
* Experience as a LIMS administrator.
* Experience with facility start-up projects (brown field or green field) is desirable.
* Experience in Training of personnel.
* Previous experience in a Quality Control/GMP environment is required.
Qualifications
* University degree in related science/quality discipline required.
* Behavioural Competencies Excellent communication, interpersonal and presentation skills
* Ability to think critically and demonstrate troubleshooting and problem-solving skills.
* Comfortable in a fast-paced working environment and able to adjust workload based upon changing priorities.
* Collaborative and inclusive approach to work and your colleagues.
* Flexible approach to work and a positive attitude will be a good fit within the team dynamic.
* Engage cross functionally in conjunction with a site-based team.
About Us
We are WuXi Biologics, a world-class biologics services provider from discovery, through to commercialization, with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. We have sites/offices in China, US, EU, and Asia, and currently employ over 10,000 employees worldwide, providing services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies.