LIMS System Administrator

Primary:

* Maintain and update the workflows in the lab systems.

* Manage changes and requests in the IT ticketing / change system (e.g. Service Now)

* Help with system and instrument integrations, making configuration changes and coordinating with Global DD&T function.

* Perform master data updates to support routine business changes and improvements.

* Support and resolve master data issues and perform routine administrative activities.

* Create and maintain method verification scripts and system documentation to support new functionality developments and routine updates.

* Provide first tier application support for routine issues, including end-user questions and assistance resolving usage issues.

* Support validation activities for ongoing projects.

* Integrate laboratory instruments with scientific software packages.

* Perform operations in the lab systems in compliance with regulations, and global and local requirements.

* Represent company interests with the Global LIMS and MODA teams and act as liaison between Global and MBO site functions.

Secondary:

* Maintain positive working relations with internal/external stakeholders and users.

* Ensure full compliance with cGMP and Quality system requirements for all activities. Responsible for overall regulatory inspection readiness and compliance with quality requirements.

* Excellent verbal and written communication skills.

* Ensure that the Quality Control labs computer systems /programs are properly maintained and in GxP compliance.

Maintain individual training plans and ensure the QC team and other users remain complaint and up to date with training requirements. Provide Training for new modules and new employees.

* Perform responsibilities in compliance with Evonik quality systems

* Provide support to Quality labs..

* Communicate with and support QA/QC Site personnel and global IT resources

* Adhere to all company safety, health and environmental policies, procedures and directives

Conduct all laboratory activities in a safe manner by use of MSDS to establish chemical hazards, observes the appropriate laboratory procedures and reports all incidents that could threaten the safety of laboratory personnel

* Qualifications - If you were transferred to a new position, list the specific education, skills, training, and relevant experience (in a similar or lower level position) that your replacement would need to qualify for this position.

* Bachelor's degree in Chemistry or other relevant science with 7 - 15 years of experience in a quality control laboratory environment (or) Master's degree with 4 - 8 years of experience

* Certified training in IT related field or equivalent

* Familiarity with IT systems in a Laboratory environment and 1 or more years of experience using LIMS or similar systems.

* Proficient in Windows environment

* Familiarity with GMP requirements

* Strong written and verbal communication skills

* Thrives working in a team-based environment but also enjoys working independently.

* Familiarity with laboratory equipment (GC, HPLC, spectrophotometer, plate readers, FTIR, UV-Vis, etc.)

* 2 to 5 years related LIMS experience: configuration, validation, implementation, and/or system admin.

* 3 to 6 years pharmaceutical or biopharmaceutical industry experience.

* Configuration / development experience with LabVantage LIMS.

* Have knowledge of the LabVantage or similar LIMS systems and understanding of the processes they support.

* Understanding of the systems when making decisions to determine whether process changes will have an impact on Data Integrity or the validated state of the lab systems.

* Collaborate and engage with the business / personnel in the labs.