Senior Quality Control Analyst

Morgan McKinley; Carlow; On-site; EUR 70,000 - 90,000; Full time

Job summary

Morgan McKinley is seeking a QC Lead Analyst for a state-of-the-art Quality Control laboratory in Ireland. You will lead analytical testing transfers, validation and release testing for vaccines and biologics, working under the QC Manager in a two-cycle rotating shift pattern.

You will apply ELISA, HPLC and compendial methods, drive CAPA and audits, and contribute to continuous improvement within a compliant GMP environment. A minimum 4 years in pharma labs is required.

Qualifications

• Bachelor's degree or higher in Analytical Chemistry, Biochemistry or a closely related science.
• At least 4 years’ experience in a pharmaceutical laboratory.
• Good working knowledge of HPLC systems and associated software.
• Good working knowledge of ELISA techniques and SoftMax Pro software.
• Sound understanding of cGMP, GLP and Quality Management Systems.

Responsibilities

• Work under the direction of the QC Manager, ensuring compliance with safety policies, cGMP, cGLP and regulatory requirements.
• Participate in daily QC meetings, communicating testing progress and deviations.
• Contribute to writing and revision of SOPs, training materials and quality documentation.
• Carry out allocated analytical testing and review activities as part of the QC team.
• Perform ELISA, HPLC and compendial assays in accordance with GMP requirements.
• Peer-review testing documentation to ensure data integrity and QFTime KPIs.
• Help with laboratory investigations related to OOS results.
• Support audits and inspections to maintain compliance and readiness.
• Participate in internal/external audits as an auditee for assigned areas.
• Drive continuous improvement using root cause analysis and tools like FMEA and 5 Whys.
• Collaborate to promote a safe, compliant, quality-focused lab culture.

Skills

ELISA

HPLC

Compendial testing

cGMP knowledge

Education

Bachelor's degree or higher in Analytical Chemistry / Biochemistry or related

Tools

SoftMax Pro

Job description

Join a supportive and growing team within a state-of-the-art Quality Control laboratory supporting the testing of biologics and vaccines. This is an excellent opportunity to join an established pharmaceutical manufacturing environment with a strong focus on quality, compliance and continuous improvement.

The QC Lead Analyst will report directly to the QC Manager and play an important role in supporting the continued development and expansion of the laboratory. Key responsibilities will include analytical method transfers, method validation and commercial product testing. The team operates on a two-cycle shift pattern.

Occasional travel may be required for training purposes.

The ideal candidate will have 4+ years’ experience in a pharmaceutical laboratory, ideally with hands-on experience in ELISA, HPLC and compendial testing, along with relevant laboratory systems and software. A key aspect of the role is performing analytical testing to support the release of key pharmaceutical products.

What you will do

Bring your technical knowledge, initiative and leadership skills to carry out the following responsibilities:

• Work under the direction of the Quality Control Manager, ensuring compliance with company safety policies, cGMP, cGLP, global policies, procedures, guidelines and applicable regulatory requirements in all day-to-day activities.
• Participate in daily QC Tier 1 meetings, ensuring effective communication of testing progress, deviations and other relevant updates.
• Contribute to the writing, revision and implementation of operational procedures, training materials and maintenance procedures across relevant Quality systems, ensuring all work is performed in accordance with approved documentation.
• Work as part of the QC team, carrying out allocated analytical testing and review activities.
• Perform a range of analytical techniques, including but not limited to ELISA, HPLC and compendial assays, in accordance with GMP requirements.
• Peer-review testing documentation, ensuring data integrity requirements are met and QC Right First Time KPIs are achieved.
• Participate in laboratory investigations relating to out-of-specification (OOS) results.
• Support audit and inspection activities, helping to maintain departmental compliance and inspection readiness.
• Participate in internal and external audits and inspections, acting as an auditee for assigned areas of responsibility.
• Drive continuous improvement initiatives and conduct root cause analysis into system failures and substandard equipment performance, using appropriate tools and methodologies such as FMEA, fishbone diagrams and the 5 Whys.
• Collaborate with colleagues to promote a safe, compliant and quality-focused laboratory culture.

What skills you will need

To be successful in this role, you will ideally have:

• A Bachelor's degree or higher, preferably in Analytical Chemistry, Biochemistry or a closely related scientific discipline.
• At least 4 years’ experience working in a pharmaceutical laboratory.
• A good working knowledge of HPLC systems and associated software.
• A good working knowledge of ELISA techniques and SoftMax Pro software.
• A sound understanding of cGMP, GLP and Quality Management Systems.

About the opportunity

You will be joining an established pharmaceutical manufacturing site specialising in the manufacture and commercial supply of vaccines, biologics and small-molecule drug products. The site features modern production facilities, advanced laboratories and temperature-controlled warehousing, supporting high-quality manufacturing and product supply.

The organisation is committed to quality, innovation, continuous improvement and employee development. It values collaboration, technical excellence and the contribution of diverse teams, and is an equal opportunity employer dedicated to fostering an inclusive and supportive working environment.