Quality Control Analyst
Job Responsibilities:
- Perform analysis on finished drug product, in process materials and stability samples – UV, HPLC, wet chemistry.
- 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 Supervisor.
- 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 Supervisor.
- 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.
Education/Experience:
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 behaviors 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
