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Quality Technician – Shannon – Incoming & Shipping
About Aerogen:
Headquartered in the vibrant city of Galway, Ireland, with offices around the world, Aerogen is proud to be the world leader in acute care aerosol drug delivery. Recognised through multiple MedTech awards and ten-time winner of the Zenith award for Respiratory Care Excellence in North America, collectively our employees make a difference to patients’ lives every day, having already reached 20 million patients in over 80 countries.
Our talented and skilled team collaborate to innovate, challenge and test not only in relation to our products but every facet of how we work. We lead the way, finding innovative solutions to even the most complex problems, all in the name of delivering better patient care.
Our business is growing rapidly across the globe and as we grow, our core culture of “We Care” universally connects us. We believe that your ambition and integrity fuels ours and we are committed to supporting our employees to reach their full potential through tangible investment in their careers. Join us as we continue to #discoverbetter.
What is the role?
Currently the duties and responsibilities of this position are performed by the ‘Incoming Inspector’. In addition to incoming inspection duties the Technician (Incoming Inspection) will progress the necessary documentation from a Quality perspective to facilitate on time shipments to all locations served by Aerogen LTD. This position interacts closely with Supply Chain, Supplier Quality, Operations, and Manufacturing Quality and requires attention to detail and ability to accurately report any discrepancies in drawings/documentation etc.
What are the key responsibilities?
- Demonstrate strong performance and a clear identifiable work ethos within the Quality Engineering Team.
- Display attention to detail and the ability to report any deviations in documentation /quantities to the Senior Quality Manager
- Complete all incoming inspection requirements as per defined inspection plans in a timely manner.
- Review the incoming inspection process on an ongoing basis for potential improvements.
- Review and ensure that all shipment documentation is correct and that all lots and quantities conform to the necessary documentation.
- Work closely with all stakeholders on any issues that are noted either associated with incoming inspection and in the preparation of product for shipment.
- Participate in MRB (Material Review Board) and material disposition duties as required
- Support for incoming inspection changes and improvements including reduced inspection initiatives.
- Participate in Corrective Action activities relating to incoming inspection and NC/CAPA System.
- Participate in all relevant internal, 3rd party and regulatory audits.
- Overall responsibility for GMP standards and compliance manufacturing applicable to the incoming inspection and shipment areas
- Maintain compliance with relevant ISO and FDA Quality System regulations
- Perform other assigned tasks and support all aspects of the Quality System as directed by the Senior Quality Manager
What education and experience are required?
- BE/BS Degree. (Level 7 Diploma or recognized equivalent
- At least two years Quality Engineering experience or related role within the medical device/pharma industry.
What key skills will make you great at the role?
- Ability to work on your own initiative.
- Strong team member with the ability to comprehend Engineering drawings, Certificates of Conformity (COC) and Certificates of Analysis (COA
- Ability to perform measurements using ‘Drop gauges’ Digital callipers, Verniers etc.
- Good communication skills.
- Thorough understanding of relevant parts of ISO 13485 and FDA QSR as applies to this position.
What is it like to work at Aerogen?
Our purpose is to transform patient lives and our ethos is to #discoverbetter. This also translates to how we look after our people. We want talented, passionate and engaged people to join Aerogen and build your career with us. We understand that your life evolves through different stages, and we are here to support our global team with a range of financial and non-financial rewards and benefits. There’s something for everyone! Here is an idea of what we offer:
- Excellent medical care.
- Bonus & Pension.
- ‘Aerogen Connect’ – our employee led programme which supports our global teams to unite and have fun.
- We pledge 1% of profits and time to charities and organisations.
Aerogen is committed to promoting diversity, inclusion and equality in the workplace. If you have any difficulty using our application process, please contact us by emailing careers@aerogen.com. Please include your name and preferred method of contact.
Ireland - Shannon
QA/RA
Quality Technician – Shannon – Incoming & Shipping
Shannon
Ireland