REBECCA CLARKE
Swords,Co. Dublin
Summary
Accomplished professional with extensive expertise in Quality Management Systems, manufacturing operations, laboratory testing and analysis, and compliance and standards. Demonstrates proficiency in handling and processing samples, utilizing analytical instrumentation, and maintaining laboratory information management systems. . Skilled in troubleshooting equipment, deviation trending, and implementing Hazard Analysis and Critical Control Points (HACCP). Committed to continuous improvement and problem-solving within laboratory environments. Supports busy, productive environments by working with focus, drive, and attention to detail.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Upstream Bioprocessing Associate
MSD Dunboyne
Swords, Dublin
07.2024 - Current
- While working at MSD Dunboyne as an Upstream Bioprocessing Associate, I have gained extensive knowledge of biopharmaceuticals, as well as experience working with a self-directed work team (SDWT) in a cutting-edge, single-use, multi-product biotech facility.
- Executed manufacturing operations for biologic drug substance production in compliance with GMP, ensuring adherence to production targets.
- Generated and updated SOPs and work instructions to ensure regulatory compliance.
- Participated in Tier 0 and Tier 1 meetings to address production challenges, providing status updates on KPIs, and supporting team goals.
- Conducted routine and non-routine sample handling and aliquoting for testing, adhering to GLP and SOPs.
- Recorded samples within GLIMS, or logbooks, and label accordingly.
- Calibrated and standardized bioreactor equipment and lab instruments ensure compliance with regulatory requirements.
- Proficient in the use of different systems, such as MES, gLIMS, MODA, Delta V, and COMET (SAP).
- Optimized workflow through efficient resource allocation and task scheduling, resulting in streamlined operations.
- Carried out day-to-day duties accurately and efficiently.
- Successfully delivered on tasks within tight deadlines.
- Collaborated with cross-functional teams to support project development initiatives.
- Assisted in the coordination of training sessions for new staff members.
Pharmacy Dispensary Assistant
Foley's Pharmacy
02.2021 - 01.2024
- Supported pharmacists with dispensing medication and addressing customer inquiries, maintain accurate records of pharmaceutical transactions.
- Managed medication inventory and maintained cleanliness in adherence to safety standards.
- Ensured compliance with SOPs and assisted in carrying out inventory checks for controlled substances.
Laboratory Assistant
Beaumont Hospital
Dublin, Ireland
05.2023 - 09.2023
- Supported quality control processes by performing routine equipment calibrations.
- Assisted medical scientists with chemical and biological testing in the chemical pathology department, ensuring compliance with ISO 15189 standards.
- Operated and maintained laboratory instrumentation, including HPLC and automated analysers, ensuring consistent performance and accuracy.
- Processed and analysed QC samples, adhering to GLP and recognised any deviations from expected results, reporting promptly to supervisors.
- Participated in routine maintenance and calibration of laboratory equipment, ensuring proper functionality, and minimizing downtime.
- Assisted in specimen collection and processing for laboratory testing.
Education
Bachelors - Nutraceuticals in Health and Nutrition
Technological University Dublin
Dublin, Ireland05.2024
Skills
- Quality management systems
- Laboratory testing and analysis
- Sample handling and processing
- Analytical instrumentation
- Compliance and standards
- Quality control
- Laboratory information management systems
- Quality management
- Cell cultures
- Hazard analysis and critical control points (HACCP)
- Good Laboratory Practice (GLP)
- Problem solving and continuous improvement
- CGMP
- Customer service training
- Hazard analysis
- Contamination control
- Aseptic trained
- SOP generation
- Issue troubleshooting
- GLIMS management
- First Aid/CPR
Languages
- Irish
- English
- French
Details
Swords, Swords, Co. Dublin, 083 805 9583
Accomplishments
- Nominated to compete in the 2024 Science Undergraduate Research Experience (SURE) conference to present my final-year dissertation
Certification
- Driving license
- Fire safety certification
- Teastas Eorpach na Gaeilge (TEG)
- First aide response certified
References
References available upon request.
Timeline
Upstream Bioprocessing Associate
MSD Dunboyne
07.2024 - Current
Laboratory Assistant
Beaumont Hospital
05.2023 - 09.2023
Pharmacy Dispensary Assistant
Foley's Pharmacy
02.2021 - 01.2024
Bachelors - Nutraceuticals in Health and Nutrition
Technological University Dublin