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Summary

The QA Laboratory analyst is responsible to perform and assist in all GLP practices within the QA micro laboratory such as laboratory stock control, cleaning, waste disposal and good hygiene practices. In addition, the person chosen will be reviewing routine ETO sterilisation cycles prior to batch release, peform routine microbiological and environmental testing as well as analytical, environmental and microbiological validations and compilation of protocols/reports. The QA laboratory analyst shall work under the supervision of the QA Section Manager in order toperform critical systems monitoring duties for Baxter Ltd. The position is also trained to assist as back-up inselected functions as requested by theQA Section Manager and in all functions related to the Q.A. laboratory analyst duties whilst also being responsible for Gamma dose settings and quarterly dose audit sample coordination and sterility testing and update documentation such as SOP‘s as requested by the QA Section Manager.

Essential Duties and Responsibilities.

• This position is also responsible to consider the aspects for Environmental health and Safety procedures to ensure that all activities within this role do not jeopardise the safety of the employees and the environment.
• Performing, reviewing, trending and supervision of routine and environmental testing, includingmanagement of the environmental testing schedule.
• LAL Endotoxin tests on finished product, waters and incoming components.
• Routine checks on untreated and treated water.
• Surface contamination testing of cleanrooms.
• Finished product and in-process component bioburden.
• Annual re-qualification of production and controlled areas.
• Maintaining QC microbiological type cultures.
• Maintaining the laboratory in good order and in a hygienic state and 6s status.
• Management of the Stock control system and ordering of new lab equipment or other stock items
• Working on research projects.
• Sterilisation and decontamination of microbiology equipment.
• Media and reagent preparation.
• Issue and review of SOPs dealing with laboratory procedures related to environmental testing.
• The QA laboratory analyst is also responsible to perform his routine work in such a way as not to pose ahazard to himself, fellow workers in the plant and the laboratory the plant facilities and to the environment ingeneral.
• The incumbent is responsible of following Baxter Environmental, Health and Safety procedures/ policiesand Best Demonstrated Practices. The QA laboratory analyst is also responsible of notifying the QA SectionManager in case of observing any Health and Safety Hazard.
• Review of routine sterilisation cycles, and the related batch file documentation.
• Quarterly Gamma sterilisation validations.
• Gamma Sterilization (including dose setting , dose mapping , dose audits and new code assessments).
• Environmental monitoring and microbiology related validations including facilities related.
• Update of SOP's and CQP’s in relation to environmental testing and microbiology
• Performing gap analysis of micro and environmental related documentation such as CQP's, SOP's etc.
• Documentation and filing of all these procedures.

Education & Qualifications

The person occupying this position requires a science-related degree.

Microbiology/laboratory techniques and experience working in a microbiology lab is considered an asset.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.

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