QC Microbiology Analyst

QC Microbiology Analyst

Currently seeking to recruit a QC Microbiology Analystto become a key member of the Quality team within a Dublin based Biotech multinational. The successful candidate will be responsible for supporting site activities related to Product Testing, performing testing of samples and laboratory duties in accordance with cGMP regulations.

Responsibilities:

• Performing bioburden testing on utility samples, drug substance and raw materials within the required hold times.
• Performing bacterial endotoxin testing on utility samples, drug substance and drug product within the required hold times.
• Perform compendial verification, method transfer/validation, and routine testing of in-process, drug substance and drug product samples in accordance with applicable procedures and cGMP requirements.
• Performing growth promotion testing of media and organism lots entering the laboratory.
• Performing microbial identifications using MALDI-TOF and MicroSEQ.
• Completing all laboratory documentation in a timely and accurate manner.
• Compliance with Standard Operating Procedures and Registered Specifications.
• Assisting in authoring and reviewing documentation, including SOPs.
• Providing support to other departments to ensure qualification and production schedules are adhered to.
• Reviewing Batch paperwork, and reconciliation of analysis performed in the laboratory.
• Ensuring that any alert/action limit excursions are investigated according to site procedures.

Qualifications and Experience:

• The ideal candidate should hold a minimum of a Level 8 degree in Microbiology or related discipline.
• At least 1 years’ experience in a pharmaceutical / healthcare laboratory or related technical function.
• A strong background in Microbiology and aseptic manufacturing is desirable but not essential.
• The successful candidate must demonstrate excellent written and verbal communication skills.
• The ability to work in a team based collaborative environment is essential.