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Expert Analytical Specialist (Shift)
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
We currently have multiple openings for QC Specialists positions within the Quality Control Laboratory team at Eli Lilly Kinsale. These positions are permanent roles based at the Kinsale site within the analytical group supporting Peptides manufacturing. Following appropriate training, the successful candidates will work a Full Rotation shift pattern (operating on a 24/7 basis – 2-days, 2-nights, 4 days off).
As a member of the Quality Control Laboratory, the QC specialist is primarily responsible for conducting various analytical tests/assays to determine the identity, quality and purity of various pharmaceutical-related analytes. For these roles, this will involve primarily supporting In-process testing for Peptides manufacturing. Driven by business needs, the need for occasional support for testing outside of the Peptides In-process labs may also arise. This may include testing support within the Small Molecule In-process lab or testing support for raw materials, intermediates, final products/batch release, reference standard characterisation, investigative/non-routine samples etc., or validation of new methods to support new product introductions (NPIs).
All work is conducted in accordance with current Good Manufacturing Practice (cGMP) requirements. Typical analytical techniques and equipment utilised as part of the role would include high performance liquid chromatography (including online HPLC/PATrols), gas chromatography, Karl Fischer titrators.
The QC Specialist will normally work under the technical supervision of an Analytical Chemist, who will provide technical oversight for the analytical testing.
You must meet the minimum qualifications outlined in the Educational Requirements section and have/obtain work authorisation in Ireland to be considered for the role.
Basic Requirements:
1. Minimum BSc (Hons) in Analytical Chemistry, Chemistry, Biochemistry or a related Laboratory Science subject required.
2. Minimum 2-years’ experience with the analytical methodology specified above within a GMP setting.
Additional Requirements:
3. Demonstrated ability to work independently, without need for direct supervision.
4. Previous experience working a shift pattern is a distinct advantage.
5. Strong technical aptitude and willingness to learn new tasks/technology
6. Ability to work independently, own tasks and training, and problem solve/troubleshoot
7. Strong collaborative skills with an ability to work effectively in a team environment
8. Excellent communication (written, oral, listening) skills
9. Excellent attention to detail and accuracy in execution
10. Customer focus - takes personal responsibility for speed, quality and accuracy of delivery
11. Self-motivated, positive and ability to work under press ure
Key responsibilities for the role may include:
12. Conducting various analytical testing as specified above (including second person verification) in accordance with cGMPs
13. Maintaining the laboratory facility, supplies and equipment in an inspection-ready state, and supporting regulatory inspections where required
14. Conducting and documenting Quality observations and investigations to completion
15. Tabulating and consolidating assay results, lead times and other performance indicators and presenting informal reports of results to immediate supervision
16. Using Lean methodologies and participating in continuous improvement projects
17. Participating in laboratory and facility processes including safety audits, procedure revision, housekeeping and improvement projects, and liaising with other departments as necessary
18. Qualification and routine maintenance of various analytical instrumentation including PAT (Process Analytical Technology)
19. Acting as a technical resource (subject matter expert) for analytical technologies
20. Training of other personnel in Analytical techniques
21. Adhering to Environmental, Health and Safety (HSE) procedures and involvement in HSE incident investigations as needed
Please note: your job title and level will be based on your experience so may differ from posting title.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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