Sr Quality Control Analyst

PE Global; Leinster; On-site; EUR 55,000 - 75,000; Full time

Job summary

PE Global is recruiting for a Senior QC Analyst – Analytical for a leading biopharmaceutical company based in Meath. This is an 11-month, onsite contract in a state-of-the-art Dunboyne facility with a 28-person QC hub in Meath, Ireland.

The role covers biological, chemical, and physical analyses (HPLC, UPLC, CE, GC), stability and drug substance testing, and validation activities to ensure cGMP compliance and quality delivery for patients.

Qualifications

• Degree or equivalent in Science/Technical/Quality or related field
• 4 years’ experience in biotechnology/pharmaceutical industry
• Excellent written and oral communication skills
• Understanding of cGMP requirements for Lab Operations/systems
• Knowledge of analytical methods: HPLC, GC, UPLC, Capillary Electrophoresis and wet chem methods

Responsibilities

• Support QC testing hub as part of the site in Dunboyne, Meath
• Conduct biological, chemical, and physical analyses using state-of-the-art instrumentation
• Assist in start-up activities and ensure cGMP/compliance across lab operations
• Collaborate with self-directed teams and hub teams to resolve issues
• Deliver within project timelines and drive continuous improvement

Skills

UPLC

CE

PA800

Deviations

Stability testing

Drug substance testing

Validation

Education

Degree in Science/Technical/Quality

Tools

HPLC

GC

UPLC

Capillary Electrophoresis

Wet chemistry

Job description

PE Global is currently recruiting for SR QC – Analytical on behalf of a leading company based in Meath.

This is an initial 11-month contract role. This is onsite role.

-UPLC, CE, PA800 and deviations, compliance and raw materials experience in Biopharmaceutical industry

-Work will include Stability, drug substance testing and validation activities

- No graduates will be accepted

-Onsite

-Team of 28 people

Job Purpose – Senior QC Analyst – Analytical Laboratory

• Primary duties of this role will be part of the 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 QC Senior Analyst 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 commitment culture that support Quality, EHS, Learning and Continuous Improvement.
• The QC Senior Analyst 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.

Key Accountabilities

• Strong project management skills to support project delivery and operational readiness.
• Strong stakeholder management skills to manage both internal and external stakeholders that support the site.
• A proven ability to deliver on tight timelines.
• Excellent influencing/collaboration skills and teamwork mindset.
• Excellent trouble shooting and problem-solving skills as well as an ability to coach and mentor self-directed teams through complex problem solving.
• Ability to challenge the status quo with a continuous improvement mindset.
• Ability to think logically and be proactive under pressure.
• Proven ability in using a wide variety of lean tools and building capability within teams.
• Change agent who will support the organisation with good change management tools and techniques.

Educational and Experience Requirements:

• Degree Qualification (Science/Technical/Quality or related)
• 4 years’ experience in the biotechnology and/or pharmaceutical industry
• Excellent written and oral communication skills
• An understanding of cGMP requirements of Lab Operations and/or systems and compliance
• An understanding of analytical methodology – HPLC, GC, UPLC, Capillary Electrophoresis and wet chem methods

Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland