John Hickey
Tipperary,Ireland
Summary
Results-driven professional with expertise in team supervision, scheduling, and shift handover. Acts as the first point of escalation for out-of-specification issues and non-conformances. Skilled in cross-functional training, SOP development, and analytical testing with review authority. Experienced in audits and CAPA, with strong capabilities in LIMS data management and a wide range of analytical techniques. Seeking to leverage analytical skills to drive innovation in laboratory settings.
Overview
1
1
Certification
7
7
years of professional experience
Work history
QC Chemistry Analyst
Regeneron Pharmaceuticals
Raheen, Limerick
2021.03 - 2025.02
- Performed testing including HPLC, UV spectroscopy, and endotoxin testing on samples at key stages of manufacturing process, developing strong practical understanding of production workflows and directly liaising with manufacturing team on regular basis to communicate sample status, discuss results, and resolve any issues affecting progression.
- Reviewed QC raw data for up to 10 samples daily across 10–15 qualified instruments and methods, accurately recording results in Nautilus LIMS and Microsoft Excel, and progressed to senior reviewer and sign-off authority, authorising colleague test results and audit trails.
- Evaluated and interpreted analytical results against defined acceptance criteria across in-process, release, and stability testing, providing concise and quantitative data analysis; identified and escalated trending issues.
- Conducted and documented laboratory investigations including OOS and OOT events to completion, applying root cause analysis and CAPA principles.
- Participated in calibration, qualification, and validation of laboratory instruments and new testing techniques, and maintained quality control trails to verify accuracy of testing and instrumentation.
- Acted as certified trainer and technical SME across all qualified tests in Day 1 Chemistry lab, onboarding and developing approximately 20 analysts over 4 years.
- Maintained laboratory audit and inspection readiness through internal audits of laboratory systems; directly engaged with HPRA and FDA inspectors during regulatory audits in tester and reviewer roles.
- Occasionally deputised for QC Team Lead in their absence, taking responsibility for scheduling work across team and conducting formal shift handovers along with other oral presentations, ensuring continuity of testing operations and clear communication between incoming and outgoing shifts.
- Fostered continuous improvement and 5S culture within team, ensuring high housekeeping and Health & Safety standards; served as EHS Safety Champion for QC Chemistry laboratory, recognised as Top Talent for Day 1 Chemistry Lab, 2024.
- Worked in high-intensity, around the clock analytical laboratory on a 4-cycle shift pattern, supporting continuous manufacturing operations across in-process, release, and stability testing programmes, contributing to effectiveness and continuous improvement of site quality management system.
Quality Control Analyst
Pinewood Healthcare
Clonmel, Tipperary
2019.06 - 2021.05
- Performed QC testing on raw materials and finished product samples across a portfolio of over 40 products using HPLC, UV, GC, Karl Fischer (KF) titration, and IR spectroscopy, evaluating results against defined acceptance criteria.
- Reviewed and signed off on test results, ensuring quality oversight and adherence to standards within the laboratory.
- Trained and onboarded new analysts; maintained meticulous laboratory records to uphold data integrity and regulatory compliance.
- Participated in regulatory and internal audits, showcasing GMP compliance and technical competency to auditors.
Quality Assurance Intern
Dawn Farm Foods
Naas, Kildare
2018.01 - 2018.07
- Performed functional testing on products, ensuring adherence to defined requirements.
- Adhered to Standard Operating Procedures and Good Manufacturing Practice, ensuring compliance and quality assurance across all role aspects.
- Completed 6 month placement in high intensity food manufacturing environment, gaining hands-on exposure to QA operations, SOPs, GMP, and standard work practices, enhancing understanding of industry standards.
- Compiled and maintained documentation, promoting transparency in operations.
- Participated in project meetings, aiding in communication between teams.
Education
Bachelor of Science - Bioscience
University of Limerick
Limerick 09/2015 - 05/2019
Skills
- HPLC
- Instrument calibration
- Analytical testing authority
- Deviation investigation
- SOP development
- Regulatory participation
- Quality assurance support
- Nautilus LIMS
- 5S methodology
- Cross-functional training
- Team supervision
- Escalation point
Certification
- Full Irish Driving Licence (10 years)
- Microsoft Office Specialist – PowerPoint
- Covid-19 Safety & Compliance Trainer
- ECDL – European Computer Driving Licence
- CPR & Basic Life Support certified
- Green Certificate L5 & L6 – QQI (Distinction, 2021/22)
Affiliations
- Farming - In my off time and weekends I love coming home to the family farm where my Dad and I farm together
- Travelling - Love exploring different countries and Ireland and getting the chance to explore new cultures and meet new people
- Sports - Keen interest in all sports and I am a member in my local golf club Cahir park
Accomplishments
Awarded the Regeneron Top talent award in 2024 as a recognition for the skills and leadership that I was able to provide to the Regeneron chemistry team
References
References available upon request.
INTERESTS
Hurling, GAA, Hiking, Swimming, Fitness, Photography, Cooking, Reading, Travel, Music Festivals
AWARDS & RECOGNITION
- Thesis grade B1 – University of Limerick,
- EHS Safety Champion for QC Chemistry Lab Regeneron
Timeline
QC Chemistry Analyst
Regeneron Pharmaceuticals
2021.03 - 2025.02
Quality Control Analyst
Pinewood Healthcare
2019.06 - 2021.05
Quality Assurance Intern
Dawn Farm Foods
2018.01 - 2018.07
Bachelor of Science - Bioscience
University of Limerick
09/2015 - 05/2019