LSC have a great contract opportunity for a QC Analyst to join a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long-term market support. The team on site grow, purify, formulate, and bulk fill mammalian cell culture derived APIs for medicines intended for human use.
If you have 3+ years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Perform primary review of QC raw data and trend results.
- Prepare protocols, summaries, and reports, including documents submitted directly to pharmaceutical regulatory agencies.
- Draft and update QC Standard Operating Procedures (SOPs).
- Act as a technical subject matter expert (SME) and provide training and support to other analysts in areas of expertise.
- Evaluate analytical and microbiological results against defined acceptance criteria.
- Conduct and document laboratory investigations through to completion.
- Maintain the laboratory in a constant state of audit and inspection readiness.
- Interact directly with regulatory agency inspectors during audits and inspections.
- Interface with other BioMarin functions including Manufacturing, Quality Assurance, Facilities, and external contractors as required.
- Other duties as assigned.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- BSc in a scientific or engineering discipline with 5+ years of relevant cGMP laboratory experience.
- Or MSc with 3+ years of relevant cGMP laboratory experience.
- Excellent written and verbal communication skills.
- Strong customer focus, with personal accountability for speed, quality, and accuracy of delivery.
- Self-motivated, with the ability to work under pressure in a fast-paced environment.
- Team oriented, with active participation in team development and continuous improvement, including standard work and 5S.
- Demonstrated success in achieving goals as part of a high performing team in a growing organisation.
- Proven adaptability and flexibility to support an evolving operational environment.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Kathy Gillen at LSC on 021 4777329 if you have any more questions about this role!
