Job Title

Microbiology Analyst

Requisition

JR000015212 Microbiology Analyst (Open)

Location

Dublin, IRL

Additional Locations

Job Description Summary

The Quality Control (QC) Microbiology Analyst is responsible for QC Microbiology testing within the QC laboratory and CPMF Manufacturing Area to support the College Park Manufacturing Facility. The role will ensure adherence with regulatory and best practice requirements while delivering consistently for the internal and external customers.

Job Description

Essential Functions

Work within the QC Microbiology laboratory to ensure consistent delivery to customersAbility to perform key tasks such as:Environmental MonitoringWater SamplingWater TestingTotal Organic Carbon TestingConductivity TestingBioburden TestingEndotoxin TestingCompendial VerificationsMethod TransferValidationsGrowth Promotion TestingIn-process testingData analysis and trendingPerform testing and ensure that the testing schedule is adhered to and the results reported in a timely manner, escalation of any issues LIR/OOS/OOT/etc.Liaise with other functions on site to facilitate testing to ensure schedule adherence.Oversight of contract testing laboratories associated with Microbiological Testing– shipping, reconciliation and trending of test resultsDevelop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.Participate in the Compendial verification, validation and transfer of Microbiological Testing in house.Prepare for and support internal and external audits (e.g. HPRA, FDA, Corporate etc.).Lead and implement initiatives that add value to QC Microbiology and site operations.

Minimum Requirements

Education / Experience / Skills:

Minimum BSc in Science or equivalent level (level 7 Laboratory apprentice qualification)Minimum 2 years’ experience in a similar roleMust include role(s) within a QC settingSolid experience of Bioburden, Endotoxin and Environmental Monitoring preferredExperience with method validation/method development preferablePharmaceutical drug/process development experience preferableSelf-starter with strong work ethicGood interpersonal skills are required, as is the ability to communicate well, both verbally and written.Must be able to function effectively in a teamwork environmentAbility to identify, execute and prioritize work tasks/projects and know when to escalateExcellent problem-solving, decision-making and communication skillsGood computer skills, including proficiency with business and technical software (Word, Access, Excel, PowerPoint)Ability to plan, organize, and prioritize effectivelyGood technical and compliance-based writing skillsHigh levels of integrity and trustworthiness

Organizational Relationship/Scope:

Reporting to the QC & Microbiology Lead the QC Microbiology Analyst is required to perform testing and analysis within QC Microbiology. The QC Microbiology Analyst works closely with Senior QC Microbiology Analyst and QC Microbiology Analysts within the lab and cross functionally with including but not limited to QC, QA, Validation, Engineering and Manufacturing across College Park. The QC Microbiology Analyst is also required to liaise with and work with the wider Global Quality function.

Working Conditions:

This is a lab-based role.Working hours flexibility required.Availability to work weekends required.

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.  They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

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