QC Microbiologist
Location: Cork, Little Island
Duration: 18 months
Hours: 39 (Mon to Fri, regular working hours)
The position will be located at the Little Island site and will be part of the Quality Team.
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.
roles 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).
how to succeed
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.
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.
details
This role offers a very competitive hourly rate.
This contract will run for an 18 month duration (maternity cover) with the possibility of extensions.
Hybrid position (3 days on-site, 2 at home)
you are welcome here
Janssen is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
about Johnson & Johnson Innovative Medicine
Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.
Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.
We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.
Janssen UK: https://www.janssen.com/uk/
Janssen Ireland: https://www.janssen.com/ireland/
application process
We are looking to process the first round of applications within the next 3 working days.
We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available.
questions
If you would like some additional information about the role please contact: simone.strong@randstadsourceright.co.uk
Diversity, Equity & Inclusion
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.
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