QC Specialist
On behalf our our Clinical Stage Gene Therapy Company we are sourcing a QC Specialist to join their Team.
As a QC Specialist, you will be responsible for ensuring continued Good Manufacturing Practice (GMP)-compliant activities within QC to support the manufacture and release of plasmid and gene therapy products.
This role will be a part of aiding the start-up of a new GMP facility for the production of gene therapy products. As such, it will involve participating in and providing subject matter expertise in equipment qualification, method transfer and routine in-process and release testing within the QC labs, in addition to other QC-supporting activities.
Key Responsibilities
- Write, review and update SOPs and related documentation for QC
- Liaise with cross-functional departments (i.e. Engineering, Supply Chain and QA Validation) to introduce equipment into the new QC labs in the facility, including generation of life cycle and qualification documents
- Participate in method validation and or technical transfer execution as needed
- Generate method validation/technical transfer protocols and/or reports
- Perform routine analytical testing for in-process and release samples
- Support testing at external contract labs for raw materials and final product
- Training/mentoring of junior analysts on methods and corresponding instrumentation
- Operation and maintenance of laboratory equipment ensuring all equipment is calibrated and suitable for use in alignment with test schedule
- Record Out-of-Specification and non-conformances. Lead investigations and implementation of corrective action(s) where applicable
- Provide Subject Matter Expertise as part of regulatory inspections
Key Job Competencies
- Experience of working within a quality environment
- High level of attention to detail
- Problem Solving - Identifies and resolves problems in a timely manner; able to gather and analyse information; develops alternative solutions; works well in group problem solving situations
- Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to compliment data; Designs workflows and procedures
Job background
- BSc in a scientific discipline e.g. Biochemistry, Chemistry
- Minimum 3 years experience working in a GMP environment
- Experience in working with any or numerous of the following methods; qPCR, HPLC, Western Blot, SDS-PAGE, DNA extraction, Spectrophotometry
- Experience with mammalian cell culture and/or flow cytometry preferred
- Proficiency in Microsoft Office software preferred, specifically Word, Excel and PowerPoint
- Wants to learn and have a natural curiosity to understand systems and processes
- Ability to work in a fast-paced environment essential
This is the chance to join a start up organisation coupled with excellent salary & full Benefits package
Candidates must hold a valid work permit/visa or EU citizenship to be considered.
To Apply:
If this job sounds ideal to you & you want to enquire in complete confidence or make an application, contact Darren Brown in Cpl Limerick on 087 405 3774 or email your details to [email protected]
