QC Micro Analyst (Shift)

QC Micro Analyst(Shift)
RK9989
12 Months
Cork



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



Duties:

• 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, i.e., internal investigations and regulatory inspectors etc.
• Proactively identifies and implements lab process improvements.
• Supports lean initiatives in the area of lab operations, i.e. standard work, level loading, test method execution, documentation updates and equipment qualification etc.
• Supports Team leader on day to day testing operations.

• The position of QC analyst requires a degree in a science discipline.
• A minimum of 2 years experience within the Pharmaceutical Industry
• Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and aseptic products.
• Experience with Bioburden, Endotoxin, Sterility Testing, Microbial Identification using genetic methods