Senior QC Analyst
Our Client a medical device company in Cork are looking to recruit a Senior QC Analyst.
The candidate must have superior technical knowledge of analytical techniques and knowledge of related laboratory equipment in the area of microbiological, chemistry and biochemistry testing of Bulk API and final drug product. The candidate must have prior experience of working in an IMB/FDA regulated facility.
What will I be doing
- Performing a wide variety of microbiology, chemistry or biochemistry testing to support utilities, raw material, in process, bulk and drug product release.
- Rapid turnaround of samples to meet manufacturing needs.
- Performing data review and approval.
- Providing support and advice to manufacturing on QC related topics.
- Initiating and leading investigations where required.
- Initiates and completes, CAPAs and Change Controls in accordance with site procedure
- Writes new and updates current procedures on electronic documentation system.
- Providing training to other analysts and to manufacturing personnel.
- Presents technical analytical data clearly and concisely data to customers
- Proactively identifies and implements lab process improvements.
- Supports lean initiatives in the area of lab operations, execution, documentation updates and equipment qualification etc.
- Supports Team leader on day to day testing operations.
What do I need
- Sterility Testing
- Microbial Identification using genetic methods
- Clear communication skills
- Results and performance driven
- Problem solving and attention to detail
- Good time management
- Good organisational skills
- Experience with electronic systems such as LIMS, Electronic Lab notebooks, Empower, Trackwise
- 2 years' experience within the Pharmaceutical Industry
- Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and aseptic products.
For further information on this Senior QC Analyst role in Cork please contact Jenny Dore on 021 2066287 / firstname.lastname@example.org
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