QC Analyst / QC Analytical Specialist

Morgan McKinley; Carlow; On-site; EUR 42,000 - 64,000; Full time

Job summary

Morgan McKinley is recruiting for a QC Analyst/Senior QC Technician/Analytical Specialist at a strategic manufacturing site in Ireland. You will lead analytical method transfers, validations, and release testing for world-leading biologics and vaccines.

Reporting to the QC Manager, the role emphasizes compliance with GMP/GLP, data integrity, and collaboration across cross-functional teams in a high-growth, quality-driven environment.

Qualifications

• GMP/GLP compliance in pharmaceutical testing.
• Experience with HPLC, Capillary Electrophoresis, ELISA, and cell-based assays.
• Knowledge of data integrity and QA processes.
• Ability to draft and revise SOPs and technical procedures.

Responsibilities

• Perform analytical testing across multiple techniques per GMP requirements.
• Lead analytical method transfers and validation for products.
• Ensure data integrity and peer-review documentation to meet KPIs.
• Support OOS investigations and continuous improvement initiatives.
• Assist in audits and regulatory support as SME.

Skills

GMP/GLP familiarity

HPLC methods

Cell-based assays

Data integrity & QA

SOP drafting

LIMS usage

Education

Bachelor’s degree or higher in Analytical Chemistry or Biochemistry

Tools

LIMS

Job description

Shift Patterns: Multiple options available

Travel: Occasional travel may be required for training purposes

The Opportunity

Join a high-growth, supportive team at a strategic manufacturing site dedicated to the analysis of world-leading Biologics and Vaccines. Operating within a cutting-edge Quality Operations laboratory, you will play a pivotal role in a facility that serves as a cornerstone for global pharmaceutical supply.

Reporting directly to the QC Manager, the QC Analyst / Senior QC Technician / QC Analytical Specialist will support the continued expansion of our laboratory, spearheading analytical method transfers, validations, and commercial release testing.

Key Responsibilities

We are looking for energetic, innovative, and detail-oriented professionals to carry out the following:

• Advanced Laboratory Testing:
• Perform a variety of complex analytical techniques, including HPLC (HIC, CE, IEX, HP-SEC), Capillary Electrophoresis, ELISA, Cell-Based Assays, Cell Culture, and other compendial test methods.
• Execute Sterility Testing and routine laboratory operations in strict compliance with GMP/GLP requirements.
• Utilize Laboratory Information Management Systems (LIMS) for sample tracking and data management.
• Compliance & Method Transfers:
• Lead and support Analytical Method Transfers and validation protocols for new and existing drug products.
• Ensure all day-to-day operations align with company safety policies, global regulatory guidelines, and cGMP/cGLP requirements.
• Data Integrity & Peer Review:
• Peer-review testing documentation to ensure absolute data integrity and consistently meet "Right First Time" KPIs.
• Ensure timely completion and processing of all assigned analytical data.
• Investigations & Continuous Improvement:
• Lead and support laboratory aspects of OOS (Out of Specification) investigations.
• Drive a safety-first, compliant culture on-site.
• Perform root cause analysis on system or equipment issues using standard continuous improvement tools (e.g., FMEA, Fishbone diagrams, 5 Whys).
• Audits & Communication:
• Participate in daily QC Tier 1 meetings to report on testing progress, scheduling, and deviations.
• Draft, revise, and roll out accurate SOPs, technical procedures, and training materials.
• Provide support during internal and external regulatory audits, acting as a subject matter expert/auditee for assigned areas.

What Skills You Will Need

To excel in this role, you will bring a blend of technical expertise and collaborative energy:

• Education: Bachelor’s Degree or higher in Analytical Chemistry, Biochemistry, or a closely related scientific discipline.
• Experience: 2–3 years of experience in a GMP pharmaceutical or biopharmaceutical laboratory environment.
• Technical Expertise: Strong hands-on experience with HPLC systems/software and/or cell-based assays is highly desirable.
• Quality Knowledge: A solid understanding of cGMP, GLP, Quality Management Systems (QMS), and laboratory data integrity principles.

About the Site & Culture

Our facility is a premier, highly invested commercial filling site for the launch and global supply of vaccines, biologics, and small-molecule drug products. Boasting state-of-the-art production lines and advanced testing laboratories, the site is a major employer in the South East region, attracting top-tier talent through close collaborations with regional universities.

We are proud to foster an inclusive, diverse environment where colleagues respectfully challenge ideas and collaborate to solve complex problems for the common good.

We are an equal opportunity employer. Please let us know if you require any reasonable accommodations or support during the recruitment process.