Quality Control Microbiology Analyst

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Job description

*Quality Control Microbiology Analyst*
* *
*Job Title:* Quality Control Microbiology Analyst
*Location:* Netherlands
*Job Type:* Permanent
*Job Conditions:* Full Time, 40 hours a week

A leading gene therapy pharmaceutical company is looking to hire a Quality Control Microbiology Analyst to join their QC department.
*Main purpose of the job*
The Quality Control - Microbiology Analyst will be responsible for performance of the routine/non-routine QC sampling and testing within the function of the QC Microbiology Laboratory*. *The position also entails coordination of testing activities and Quality Management System functional area responsibilities as assigned.* *
*Main Responsibilities:*

* Participate in equipment validation, method transfer/validation.
* Establish, revise, review and maintain procedures (including protocol and technical report).
* Responsible for change control and deviation related to QC operations, including assisting with LIs, OOSs, and OOTs.
* Oversee sampling and storage of QC samples and maintain retain inventory.
* Maintenance of laboratory equipment/instrument and systems to ensure compliance.
* Perform routine/non routine environmental monitoring of manufacturing facility system.
* Perform routine/non routine sampling and testing of the utility systems.
* Perform routine/non routine testing such as bioburden, endotoxin, growth promotion, Gram stain, and microbial identifications, following Standard Operating Procedures (SOPs).
* Sampling and testing of gas supplies to manufacturing suites.
* Assist with data trending and aid in compilation of trend reports.
* Write and revise SOPs, protocols and technical reports as necessary.
* Coordinate shipment of samples to contract testing laboratories and review of testing data reports, as required.
* Review test data and perform data entry, as required.
* Complete documentation in accordance with current Good Manufacturing Practices (cGMP).
* Maintain QC Microbiology related systems in compliance with industry standards.
* Initiating and completing Quality Management System activities such as deviations, change controls, out of specifications change controls as assigned.
* Executing method qualification/validation protocols and writing final reports as assigned.
*Other Responsibilities:*

* Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory of supplies, etc.
* Troubleshooting equipment and microbiological testing methods.
* Perform QC testing of in-process and product samples following SOPs.
* Training of other Analysts within the department within scope of knowledge.
* Maintaining microbiological isolates and performing identification, as required.
* Other duties, as assigned.
*Educational and Other Requirements*:

* Bachelor's degree in Microbiology or other related science.
* 1-3 years of Microbiology laboratory based experience in a QC testing capacity.
* Excellent microbiological skills are required.
* Experience in aseptic technique.
* Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory of supplies, etc.
* Capable of working with minimal supervision.
* Troubleshooting equipment and microbiological testing methods.
* Thorough understanding of industry testing requirements for QC Microbiology and experience of cGMP.
* Computer literacy (MS Word, Excel, LIMS).
* Strong communication skills.
* Ability to manage activities with challenging timelines.