The QC Senior Analyst has an important role to play in the start-up of the TIL GC Quality Control laboratory in a new biologics manufacturing facility and the routine operation of the QC laboratory when start-up is complete. The QC Senior Analyst will have specific and varying duties and some key tasks and responsibilities are outlined below. During start-up flexibility is important and responsibilities may change or other duties may arise.
- Contribute effectively to the design and implementation of quality systems in the QC laboratory
- Work with other QC personnel in the preparation and review of the required documentation in the QC laboratory, including Standard Operating Procedures, Analytical Procedures, Analytical Worksheets and Material Specifications.
- Participate, as directed, in the following activities in the QC laboratory:
- Provide expertise in a variety of analytical test procedures.
- Schedule other analysts work
- Review of other analysts documentation and test results
- Stand in for QC Executive when required
- Carry out sampling and analytical testing of raw/starting materials, Master Cell Stock, Drug Substance and Drug Products according to approved TIL GC procedures and plant schedules.
- Ensure that all testing information is recorded accurately and completely according to TILGC procedures.
- Ensure that any deviations or out of specification (OOS) results are reported immediately to the QC Executive so that corrective action may be taken.
- Lead root cause analysis in deviation investigations, OOS investigations, and change proposals. Determine CAPAs required preventing reoccurrences.
- Provide samples to contract testing laboratories and liaise with these laboratories as required.
- Training of analysts
- Minimum of a BSc Degree (life science)
- A minimum of 4 years' work experience in a regulated GMP/GLP environment
- Practical experience with HPLC systems and troubleshooting
- Practical experience in cell counting, morphology and flow cytometry is desirable.
- Experience with writing and reviewing SOP's / validation protocols
- Experience with Method transfer / validation
- Experience working in an Biologics facility, desirable but not essential
- Good time management
- Experienced in technical writing
- Ability to work on own initiative in an unsupervised manner
- Ability to adapt to changing priorities
- Ability to work independently and meeting established timelines.
- Knowledge of cGMPs.
- 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.
- Self-motivated and ability to work under pressure
Grange Castle, Ireland