QC Analyst
4 weeks ago
Job Responsibilities:
- Perform Microbiological testing analysis on, but not limited to, finished drug product, in process materials, stability samples and environmental monitoring.
- Responsible for calibration and use of laboratory instrumentation.
- Complete documentation associated with analytical results in a timely manner.
- Report and document any non-conformances to the QC Manager.
- Assist in the preparation and review of area documentation e.g. SOP's, Reports, Protocols.
- Assist in the training of other analysts.
- Ensure training compliance within assigned work area and QC.
- Perform and assist in additional duties as directed by the QC Manager.
- Ensure relevant assays are performed on samples in support of release test and stability test programs.
- Support any validation and qualification of test methods and processes.
- Facilitate laboratory investigations and support associated product investigation.
- Support Laboratory inspection and audits.
- Troubleshoot laboratory methods and instrument problems.
- Establish and monitor trend analysis program.
- Contribute to the operations of the Quality Control Laboratories.
- Liaise with all customers both internal and external.
- Record and review laboratory testing documentation to cGMP standard.
- Implement and adhere to appropriate levels of cGMP within the laboratory.
- Promote safety awareness and the established culture of IIF within the assigned work area.
- Ensure that sample analysis is conducted to meet batch disposition requirements.
To be successful in this role the following are prerequisites to application:
- Third level Qualification in Science, Engineering or equivalent is preferred though not essential.Exceptions may be considered where relevant skills/experience and correct attitude and behaviours exist (this may be supplemented by further education in parallel)
- Excellent communication and interpersonal skills
- This job description indicates the general nature and level of work expected of the incumbent.It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required of the incumbent.Incumbents may be asked to perform other duties as required
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