QC Micro Specialist 62609

As a QC Microbiology Specialist, you will play a vital role in supporting Drug Substance and Drug Product activities through a range of microbiological testing and monitoring. Your contributions will directly impact manufacturing operations, product quality, and patient safety.

Key Responsibilities Include:

• Performing cleanroom, biosafety cabinet (BSC), and isolator batch-related environmental monitoring.
• Conducting utility sampling of water systems and compressed air/gas.
• Performing in-process testing of critical manufacturing samples (HPLC and UV Spectrophotometry).
• Managing issuance, receipt, and testing of biological indicators (BIs).
• Reading and reporting of results for environmental monitoring, BIs, and aseptic qualification samples.
• Reconciling and inspecting media fill units and participating in media fill exercises.
• Performing microbial identification of isolated organisms.
• Completing laboratory documentation with accuracy and timeliness.
• Ensuring compliance with Standard Operating Procedures and Registered Specifications.
• Assisting with authoring and reviewing quality documentation.
• Supporting cross-functional teams to ensure qualification and production timelines are met.
• Reviewing laboratory records and reconciling analytical data.
• Investigating any alert/action limit excursions in accordance with established procedures.
• Receiving and processing drug substance and drug product samples.
• Promoting and adhering to lean lab and 6S practices.
• Maintaining high standards of housekeeping and safety within the laboratory.
• Performing other duties as assigned by the QC Microbiology Manager.

Qualifications & Experience:

• A minimum Level 8 degree in Microbiology or a related scientific discipline.
• At least 2 years' experience in a pharmaceutical, healthcare laboratory, or similar technical role.
• Demonstrated experience in cleanroom environments using aseptic techniques; isolator experience is a plus.
• Familiarity with HPLC and UV Spectrophotometry is desirable but not required.
• Experience using systems such as MODA, Empower, CIMS, LIMS, LES, and Veeva Vault is advantageous.
• Strong written and verbal communication skills.
• A team-oriented mindset with the ability to thrive in a collaborative work environment.

The Next Step for you:

Should this position be of interest to you please submit your CV to Barry O'Mahony from Next Generation Recruitment using the apply button.

Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions.

Applications are in strict confidence.

Next Generation will never share your data outside of our organisation without your prior written consent.

Please read our Data Protection Policy on our website.