Senior QC Analyst - Analytical Laboratory

Aphex Group; Leinster; On-site; EUR 60,000 - 90,000; Full time

Job summary

Aphex Group seeks a QC Senior Analyst for the Analytical Laboratory at the Dunboyne facility in County Meath, Ireland. The role supports the Quality Control testing function and ensures compliance with cGMP and company regulations, delivering reliable analytical results.

You will work across self-directed work teams and hub teams to drive continuous improvement, mentor colleagues, and coordinate start-up activities for state-of-the-art analyses (HPLC, GC, UPLC, capillary electrophoresis) to

Qualifications

• Degree in Science/Technical/Quality or related field.
• 4 years' experience in biotechnology and/or pharmaceutical industry.
• Excellent written and oral communication skills.
• Understanding of cGMP requirements for Laboratory Operations and related systems.
• Ability to work on own initiative and within a team.
• Knowledge of analytical methodologies (HPLC, GC, UPLC, Capillary Electrophoresis, wet chemistry).
• Familiarity with GMP, ICH, USP and global compendia regulations and guidance.
• Experience with continuous quality/process improvement tools (e.g., Lean, Six Sigma, 5S).

Responsibilities

• Support Quality Control testing and hub/self-directed teams to ensure cGMP compliance.
• Assist with start-up activities for the analytical lab at the Dunboyne facility.
• Identify and resolve issues to enable timely delivery and quality.
• Coach and mentor self-directed teams in problem solving.
• Collaborate across cross-functional teams to meet site objectives and manage risks.

Skills

Quality control

Analytical thinking

Stakeholder management

Problem solving

Project management

Continuous improvement

Team collaboration

Communication (written)

Education

Science/Technical/Quality degree

Job description

• 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 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 commit 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.

Responsibilities

• 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 problems 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.
• Proven ability through working across teams focusing on meeting and tracking to schedules and embracing and interdependent work culture as an agile team member.
• Support creation of a focus on creating a continuous mindset organisation through active coaching.
• Effective communicator with a proven ability to develop capabilities of others in a team.
• Demonstrated ability to give and receive feedback.
• Excellent trouble shooting and problem-solving skills.
• Ability to work as part of a team and on own initiative in a constructive manner.
• Flexible and self-motivated.
• Promoting a culture where diversity and inclusion is part of the DNA.
• Establishes stretch goals for self to allow the SDWT or Hub Team deliver on their priorities.
• Identifying and communicating risks in area of responsibility and across the site.
• Creating strategies and plans to manage risk within the Quality Control operation.
• Collaborates across the Network and continuous improvement teams across the Organisation.
• Collaborates with cross-functional teams to deliver the site objectives.
• For product quality, collaborates with Process Development Technical Services (PDTS) and Manufacturing Operations but is responsible for providing information to support the QMR decision.
• For safety, the individual is accountable to drive a culture of 'everyone owns safety'

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 for Laboratory Operations and/or systems and compliance.
• Required to work on their own initiative in addition to working as part of a team.
• An understanding of analytical methodology (HPLC, GC, UPLC, Capillary Electrophoresis and wet chemistry methods).
• 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).
• Proven ability around working cross functionally, focusing on meeting, and tracking to schedules and embracing an interdependent work culture.
• Organisation Skills - Ability to manage multiple priorities and know when to elevate issues for resolution.