Ascend PM are hiring a QC Microbiology Analyst to join our clients team, a pharmaceutical company based in West Dublin. This is a great Contract opportunity to join a growing team. Contact or email CV to to find out more.
Overview:
The Quality Control (QC) Microbiology Analyst is responsible for QC Microbiology testing within the QC laboratory and CPMF Manufacturing Area to support the Manufacturing Facility. The role will ensure adherence with regulatory and best practice requirements while delivering consistently for the internal and external customers.
Key Responsibilities:
* Work within the QC Microbiology laboratory to ensure consistent delivery to customers
* Ability to perform key tasks such as: Environmental Monitoring, Water Sampling, Water Testing, Bioburden Testing, Endotoxin Testing, Compendial Verifications, Validations, Growth Promotion testing of media and diluents, In-process testing, Data analysis and trending
* Perform testing and ensure that the testing schedule is adhered to and the results reported in a timely manner, escalation of any issues/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 results
* Develop 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.
Experience & Skills:
* Minimum BSc in Science or equivalent level (level 7 Laboratory apprentice qualification)
* Minimum 2 years' experience in a similar role
* Must include role(s) within a QC setting
* Solid experience of Bioburden, Endotoxin and Environmental Monitoring preferred
* Experience with method validation/method development preferable
* Pharmaceutical drug/process development experience preferable
* Self-starter with strong work ethic
* Good interpersonal skills are required, as is the ability to communicate well, both verbally and written.
* Must be able to function effectively in a teamwork environment
* Ability to identify, execute and prioritize work tasks/projects and know when to escalate
* Excellent problem-solving, decision-making and communication skills
* Good computer skills, including proficiency with business and technical software (Word, Access, Excel, PowerPoint)
* Ability to plan, organize, and prioritize effectively
* Good technical and compliance-based writing skills