QC Micro Analyst

Job Description

QC Microbiologist required for excellent Biopharma based in Cork

Excellent opportunity for a QC Micro Analyst to join a leading Biopharmaceutical company based in Cork.

The candidate will be responsible for carrying out microbiological method development and troubleshooting work, executing verification/validation protocols, writing and reviewing protocols and reports, supporting training on site QC personnel in new techniques and methods, support the preparation of regulatory submission documents and, where required, supporting the on-time release testing of pharmaceutical drug substances and drug product.

Responsibilities:

• Microbiological testing performed by the lab incl: endotoxin, bioburden, sterility, rapid methods etc.
• Testing of in-process, bulk drug substance, finished product, raw materials, packaging. Perform review of QC raw data and trend results.
• Prepare protocols, summaries, and reports-often for direct submission to pharmaceutical regulatory agencies.
• Develop, optimize, validate and troubleshoot microbiological test methods.
• Draft QC SOPs.
• Act as technical resource (SME) and train other analysts in areas of expertise.
• Evaluate results against defined acceptance criteria.
• Conduct and document laboratory investigations to completion.
• Maintain the laboratory in an inspection-ready state.
• Interact directly with regulatory agency inspectors during audits.
• Interface with other departments (Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary.

Qualifications & Experience:

• B.S. in a scientific discipline. 3 years of relevant laboratory experience (in a GMP environtment).
• Ability to work independently and meeting established timelines.
• Comfort with coordinating the activities with other staff members.
• Knowledge of cGMPs.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.