QC Specialist

We’re currently recruiting for an exciting opportunity with a Pharmaceutical organisation based in Meath. This is an excellent position for anyone who is looking to join a leading multinational who are addressing some of the world’s most challenging healthcare needs.

We are hiring for two opportunities, with 2 vacancies in each area:

1. QC Analytical Chemist – Hands on experience in HPLC / UPLC, Capillary Electrophoresis (CE), Wet Chemistry
2. QC Bioassay Specialist – Hands on experience Cell Culture, ELISA, PCR.

The QC Specialist will report directly to the Analytical Lead and will help in the expansion of the Laboratory and complete analytical method transfers and validation as well as commercial testing.

Duties:

• Primary Duties of this role will be part of Quality Control Testing Hub in the state-of-the-art single use multi-product biologics facility in Dunboyne, County Meath, Ireland.
• The organisational structure at the site will be based on self-directed work teams where decisions will be made at the level where the data exists.
• The Analytical Chemist in the Analytical laboratory will work across the site self-directed work teams and hub teams to identify and resolve issues in order to allow the site to deliver on our commit culture that support Quality, EHS, Learning and Continuous improvement.
• The QC Analytical Chemist in the Analytical Laboratory will support key laboratory start-up activities, conduct biological, chemical, and physical analyses by using state of the art laboratory instrumentation and computer systems at the new single use multi-product biotech facility in Dunboyne, County Meath, Ireland.
• The overall responsibility for this role will be to support the Quality Control testing function, ensuring compliance with cGMP and corporate regulations.
• This is a critical role within the Quality organisation to help establish the Laboratories as a hub for specialised analytical testing and create value for patients.

• 3+ years’ experience within the Biotech/Pharmaceutical industry.
• Level 7 or level 8 in Engineering, science, or related field and/or proven work experience as stated.
• Lean Six Sigma experience.
• An understanding of cGMP requirements for Laboratory Operations and/or systems and compliance.
• Analytical Chemist – experience in analytical methodology (HPLC, GC, UPLC, Capillary Electrophoresis and wet chemistry methods).
• Bioassay Specialist - Experience with Cell Based Assays, ELISA and qPCR
• An understanding of GMP, ICH, USP and global compendia regulations and guidance's,
• Demonstrated understanding of continuous quality / process improvement tools (As defined by the site, e.g., DMIAC, Lean QA, 5S etc).