Orion Group Life Sciences are currently recruiting a QC Microbiology Analyst on behalf of our Multinational Biopharmaceutical Client based in Cork on an initial 18-Month contract with potential to extend.
The QC Microbiologist ensures that all microbiological and sterility testing associated with API testing is performed in accordance with all appropriate procedures and specifications. Quality Control (Microbiology) is not confined to laboratory operations but is involved in all aspects which may concern the microbial quality of the product, such as process validation, cleaning validation, method validation/transfer, environmental monitoring, critical site utilities & services, aseptic manufacture.
Main duties and responsibilities:
· Supports QC Micro Team leader on day-to-day testing operations.
· Performs Data and QC Investigations review and approval.
· Reviews Specifications and plans for associated LIMS scheduling.
· Reviews and approves Nonconformances, CAPA’s and Change Control records.
· Plans and oversees lab related projects, i.e., Method transfer and optimisation, Equipment Qualification etc.
· Proactively identifies and drives lab process improvements.
· Trains laboratory team on specific microbiological technology.
· Provides superior technical support on specific microbiological technology.
· Supports lean initiatives in lab operations, i.e. standard work, level loading, test method execution, documentation updates and equipment qualification etc.
· Presents technical analytical data clearly and concisely data to customers, i.e., internal investigations and regulatory inspectors.
· Writes, reviews and approves technical documents e.g. protocols, APRs, specifications, filing documents.
· Keeps abreast of microbiological technology and compliance trends.
· In conjunction with the QC Micro Team Leader, identify, record and resolve any microbiology related product Quality Issues.
· Liaise with other departments in developing & maintaining the site environmental monitoring and critical utilities programmes.
· Support the Aseptic Manufacturing facility including but not limited to routine manufacturing operations, isolator operations, autoclave operations, gamma irradiation, CIP (Clean In Place) and SIP (Steam In Place).
Key Skills and Competencies required:
· Builds strong productive relationships.
· Demonstrates ability to work with teams and individuals.
· Seeks opportunities to grow and develop professionally.
· Uses best practices to improve business operations.
· Holds self-accountable for compliant and flawless execution.
· Takes personal responsibility for decisions that successfully build customer value.
· Effectively manages and adapts to change.
· Always demonstrate Integrity and Credo-based actions.
Education and Experience:
· At a minimum a Primary degree in a Microbiology/Science discipline.
· A minimum of 5 years’ experience within the Pharmaceutical Industry or relevant experience as a Microbiologist.
· Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities applicable to pharmaceuticals and aseptic products.
· Experience of managing project groups or leading teams.
· Experience with Microbiological technologies and methods.
· Expert in a wide variety of analytical techniques including but not limited to sterility testing, bioburden and endotoxin techniques, autoclave, environmental and utilities testing, and gamma irradiation.
· Knowledgeable of FDA/EMEA regulatory requirements
· Skilled in the use of problem-solving tools/techniques.
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