We are a high-performing, team based organisation, where colleagues are flexible, multi-skilled and empowered to make decisions.
A high level of initiative, energy and motivation are key role requirements, as well as organisational skills.
Reporting to the QC Lead, the primary role of the QC Analyst is to support the QC team in successful Lab & Site start-up and implementation of associated systems as the site prepares for process validation and product launch activities.
- Support the QC Laboratory to facilitate manufacturing facility start up. This involves participation in method transfers, qualification of clean rooms and clean utility qualification testing.
- Perform, microbiological/biochemical/physical/chemical analyses of QC test samples under cGMP to meet specified timelines.
- Testing of finished product, raw materials, packaging and stability.
- Perform analytical testing - HPLC, GC, SDS- Page, Endotoxin, Bioburden, EM, Sterility
- Evaluate results against defined acceptance criteria.
- Perform primary review of QC raw data and trend results.
- Prepare protocols, summaries, and reports-often for direct submission to pharmaceutical regulatory agencies.
- Develop, optimize, validate and troubleshoot analytical test methods.
- Draft QC SOPs.
- Act as technical resource and train other analysts in areas of expertise.
- Maintain the laboratory in an inspection-ready state.
- Interact directly with regulatory agency inspectors during audits.
- Conduct and document laboratory investigations.
- Interface with other BioMarin departments (Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary.
- Team Leadership - active participation team development.
- Successful track record in achieving goals as part of a team within a growing, dynamic environment.
- Demonstrated adaptability and flexibility to support a growing organisation.
B.S. in a scientific discipline with 2+ years of relevant laboratory experience.
*Ability to work independently and meeting established timelines.
* Comfort with coordinating the activities with other staff members.
* Comfort with working in a team environment
* Knowledge of cGMPs.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists