We are seeking a highly skilled Quality Assurance Specialist to join our team. The successful candidate will be based onsite at our state-of-the-art facility.
Key Responsibilities:
* Perform microbiological testing analysis on various samples, including finished drug products and in-process materials.
* 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 Quality Manager.
* Assist in the preparation and review of area documentation, such as SOPs and protocols.
* Assist in the training of other analysts.
* Ensure training compliance within assigned work areas and quality.
* Perform and assist in additional duties as directed by the Quality Manager.
* Ensure relevant assays are performed on samples in support of release test and stability test programs.
* Support validation and qualification of test methods and processes.
* Facilitate laboratory investigations and support associated product investigations.
* Support Laboratory inspection and audits.
* Troubleshoot laboratory methods and instrument problems.
* Establish and monitor trend analysis programs.
* Contribute to the operations of the Quality Control Laboratories.
* Liaise with internal and external customers.
* Record and review laboratory testing documentation to cGMP standard.
Requirements:
* Bachelor's degree in Science, Engineering, or equivalent preferred (though not essential).
* Exceptions may be considered where relevant skills/experience and correct attitude/behaviours exist.
* Excellent communication and interpersonal skills.