QC Senior Analyst
This is what you will do:
The QC Senior Microbiology Analyst will support the Bulk Drug Facility in Dublin with emphasis on microbiological testing such as Environmental Monitoring, Water sampling, TOC, Bioburden and Endotoxin.
You will be responsible for:
- Environmental and Facilities monitoring sampling and testing.
- Ensuring high cGMP, GLP standards are maintained while testing and adherence to schedules and targets to meet regulatory and business requirements.
- Validation/Qualification of Microbiology test methods and test systems such as the Endotoxin test system and Identification system.
- Represent the Microbiology department in internal and external audits where appropriate.
- Close out of actions/ recommendations identified from both internal and external audits.
- Assist in ensuring that current compliance issues and trends, both internal and site-wide, are critically evaluated and training is provided where appropriate.
- To maintain competence and keep up to date with all new technologies, procedures and methods used in the Microbiology Laboratory.
- Perform technical review of data generated in laboratory, validation protocols and reports.
- Provide Technical support to Manufacturing and Projects which the company undertakes through project participation, investigation, validation and testing activities and prepare Technical Reports as required.
- To ensure all instruments/equipment are maintained in a calibrated and operational state.
- To ensure a high standard of housekeeping and safety is maintained in the Laboratory.
- Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department.
- To keep management updated on issues arising within the laboratory.
- Scheduling of testing, review and authorization of microbial data.
- Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the Microbiology Laboratory Supervisor, QA and other relevant departments and to implement effective corrective and preventative actions while ensuring all investigations are closed with the specified lead-time.
- To train laboratory personnel and play appropriate role in the development, operation and evaluation of training/re-training programs.
You will need to have:
- Minimum of 3 years experience in cGMP Quality environment.
- Experience in testing of sterile/non-sterile pharmaceutical /biopharmaceutical products.
- Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing.
- Degree in Microbiology or related science.
- The duties of this role are generally conducted in an lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
- Excellent problem solving and root cause analysis skills.
- Routinely takes an innovative approach in developing processes and procedures that are both efficient and compliant.
- Strong organizational skills.
- Planning/scheduling of own work and subordinates and ability to delegate tasks where appropriate.
- Excellent written and oral communication skills.
- Ability to develop collaborative relationships with other functions and sites in order to achieve functional, site and company goals.