Quality Assurance Specialist

3 days ago


Limerick, Limerick, Ireland Eli Lilly and Company Full time

Eli Lilly and Company is a global healthcare leader dedicated to making life better for people around the world. Our employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.

About the Role

We are seeking a talented Quality Assurance Associate to support our new Biologics Manufacturing Facility. The ideal candidate will be responsible for providing quality leadership, direction, and governance for materials management.

Main Responsibilities
  • Provides quality leadership, direction, and governance for materials management.

  • Assures consistent implementation of Quality standards across the quality system for materials management.

  • Manages quality-related matters specific to Materials.

  • Is responsible for approving appropriate quality-related documents.

  • Performs ongoing monitoring that includes:

    • monitoring of quality systems,

    • the self-inspection program,

    • verification of the effective implementation of key GMP programs, and

    • review of systems that impact Product Quality to ensure that they operate in a state of control.

    • Establishment, maintenance, and management of a control system for and training of individuals in the specific Quality System and/or Quality Program assigned.

    • Continue to provide coaching and mentoring to operations personnel and to other QA reps on the appropriate risk management to provide appropriate and timely solutions to compliance in a business-focused fashion.

    Requirements
    • BSc (Hons) in Science, Engineering, or Quality related discipline with appropriate experience.

The ideal candidate will have high learning agility and flexibility and ability to deal with ambiguity and uncertainty. Demonstrated ability to identify and prioritize problems, develop, and implement solutions.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.



  • Limerick, Limerick, Ireland Regeneron Ireland DAC Full time

    Job Description:We are seeking a highly skilled Quality Assurance Specialist to join our team at Regeneron Ireland DAC. As a key member of our quality assurance department, you will play a critical role in ensuring the compliance and quality of our products.Responsibilities:Disposition of Products: Perform activities in support of disposition of product...


  • Limerick, Limerick, Ireland TN Ireland Full time

    We are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our quality assurance team at TN Ireland. As a member of our team, you will play a critical role in maintaining the highest standards of product quality and compliance for our computer systems.Key Responsibilities:Quality Assurance Oversight:Develop and maintain...


  • Limerick, Limerick, Ireland Regeneron Ireland DAC Full time

    Job Description:The Regeneron Quality Assurance Specialist will be responsible for ensuring compliance with quality assurance policies and procedures, GMPs, SOPs, and Regeneron Standard Requirement Documents.Key Responsibilities:Preparing and reviewing batch disposition documentation to support QP release of Formulated Drug SubstanceReviewing QC related...


  • Limerick, Limerick, Ireland PE Global Full time

    Job Description:We are seeking a highly skilled Quality Assurance Specialist to join our team at PE Global. As a QA Specialist, you will play a critical role in ensuring the quality and integrity of our client's products.Key Responsibilities:Review and approval of Clinical Trial dataMethod Development & Method Validation and Product release data reviewData...


  • Limerick, Limerick, Ireland PE Global Full time

    Job Title: Senior QA SpecialistOverviewPE Global is currently recruiting for a QA Specialist on behalf of our client based in Ireland. This position acts as a quality assurance expert for QC within an R&D environment.ResponsibilitiesReview and approval of Clinical Trial, Method Development & Method Validation and Product release data.Review of Data Integrity...


  • Limerick, Limerick, Ireland Regeneron Ireland Dac Full time

    As a key member of the Quality Assurance organization at Regeneron Ireland Dac, this role is responsible for ensuring that our IT systems and programs are robust and meet regulatory agency expectations.The position will collaborate with the IT and broader QA teams to ensure all aspects of IT-related programs comply with regulatory agency expectations and...


  • Limerick, Limerick, Ireland Frs Recruitment Full time

    A highly skilled Quality Assurance Specialist is required to join the QC team of a leading Life Science company in Limerick. This exciting role involves ensuring facilities, processes, personnel and materials/products are microbiologically tested in line with cGMP and procedural requirements.The successful candidate will manage out of specification results,...


  • Limerick, Limerick, Ireland Life Science Recruitment Full time

    Life Science Recruitment is currently seeking a Product Quality Assurance Specialist to support the activities of Operations, Engineering, and Information Management in building product quality into our products and ensuring compliance with pertinent regulations.Key Responsibilities:The successful candidate will work with various departments/groups to...


  • Limerick, Limerick, Ireland Edwards Lifescience Ireland Ltd Full time

    At Edwards Lifesciences Ireland Ltd, our team of manufacturing professionals strives to make a meaningful difference in patients' lives.The Quality Assurance Specialist/Manufacturing Inspector is a critical role that plays a key part in ensuring the quality and safety of our medical devices.We are seeking an individual with strong attention to detail and a...


  • Limerick, Limerick, Ireland Stryker Group Full time

    Job OverviewStryker Group is seeking a dedicated Quality Assurance Specialist to join our team. As a key member of the organization, you will play a critical role in ensuring the quality performance of products and processes.About the RoleThis position involves collaborating with operations, suppliers, and business functions to identify and address top...


  • Limerick, Limerick, Ireland Regeneron Ireland Dac Full time

    **Job Description**We are seeking a highly skilled Quality Assurance Specialist to join our team at Regeneron Ireland Dac. This role is responsible for ensuring the robustness of IT systems, programs, and quality events meet regulatory agency expectations.The successful candidate will be responsible for liaising with the IT and broader QA organizations to...


  • Limerick, Limerick, Ireland Regeneron Ireland DAC Full time

    Job Description:We are seeking a highly skilled Quality Assurance (QA) professional to join our team at Regeneron Ireland DAC. As a QA Specialist, you will play a critical role in ensuring the quality and compliance of our biologics manufacturing operations.Key Responsibilities:Review and approve batch disposition documentation to support QP release of...


  • Limerick, Limerick, Ireland Eli Lilly and Company Full time

    Company OverviewEli Lilly and Company is a global healthcare leader dedicated to revolutionizing the biopharmaceutical industry. Our state-of-the-art manufacturing facility in Limerick, Ireland, employs cutting-edge bioprocessing technologies to create life-saving therapies.Job DescriptionWe are seeking a highly motivated and detail-oriented Manufacturing...


  • Limerick, Limerick, Ireland Cook Medical Full time

    OverviewCook Medical seeks a highly skilled Manufacturing Quality Assurance Specialist to join our team. In this role, you will be responsible for ensuring that all products manufactured at Cook Medical meet the required quality control specifications.ResponsibilitiesInspect raw materials, finished devices, packaged devices, sterilized devices, and device...


  • Limerick, Limerick, Ireland Edwards Lifescience Ireland Ltd Full time

    Transforming Patients' Lives through Precise InspectionAbout the Role:We are seeking a highly skilled Device Quality Assurance Specialist to join our team at Edwards Lifesciences. As a key member of our manufacturing team, you will play a crucial role in ensuring the quality and safety of our medical devices.Key Responsibilities:Conduct Visual Inspections:...


  • Limerick, Limerick, Ireland Regeneron Ireland DAC Full time

    Role Overview:We are seeking a highly skilled Microbial Quality Assurance Specialist to join our team in our Manufacturing facility. In this role, you will play a key part in ensuring the quality and safety of our products by performing testing to ensure compliance with cGMP regulations.Responsibilities:Performing bioburden and endotoxin sample analysis in...


  • Limerick, Limerick, Ireland Advocate Construction Full time

    Job Description:We are seeking a highly skilled Construction Quality Assurance Specialist to join our team.This role involves conducting thorough quality control walks at job sites after construction is completed.About the Role:The successful candidate will be responsible for ensuring that all construction work meets our high standards of quality.You will...


  • Limerick, Limerick, Ireland Eli Lilly and Company Full time

    Company OverviewEli Lilly and Company is a leading global healthcare leader dedicated to revolutionizing the pharmaceutical industry through innovative biopharmaceuticals.SUMMARY OF RESPONSIBILITIESThis Senior Associate will play a critical role in maintaining quality and regulatory compliance of biopharmaceutical products within our next-generation...


  • Limerick, Limerick, Ireland Edwards Lifesciences Full time

    Job SummaryWe are seeking a highly skilled Laboratory Technician to join our team. As a key member of our quality assurance department, you will play a critical role in ensuring the highest standards of integrity and safety in our laboratory environment.


  • Limerick, Limerick, Ireland Cook Medical Full time

    Overview The primary responsibility of this role is to provide Quality Assurance support as required within Cook Medical Europe Ltd. (CMEU) This includes completing internal audits and maintaining the internal audit system; providing support to software validation, change requests, non-conformance issues and the Company's corrective and preventive action...