Senior Associate Quality Control
An exciting opportunity with an award-winning Pharmaceutical organization based in Dublin has become available. This position is ideal for those looking to join a leading multinational renowned for its excellence.
Duties:
* Plan and perform analyses efficiently and accurately.
* Execute multiple, complex routine/non-routine methods and procedures, as well as a variety of assays.
* Report, evaluate, back-up/archive, trend, and approve analytical data.
* Troubleshoot, solve problems, and communicate with stakeholders.
* Initiate and/or implement changes in controlled documents.
* Participate in audits, initiatives, and projects within the department or organization.
* Review protocols and perform assay validation and equipment qualification/verification when required.
* Introduce new techniques to the lab, including method transfers, reports, validations, and protocols.
* Contribute to regulatory filings.
* Conduct lab investigations as necessary.
* Evaluate lab practices for compliance on a continuous basis.
* Approve lab results.
* Interact with outside resources.
* Coordinate LIMS data for commercial and import testing on site where applicable.
* Represent the department/organization on various teams and train others.
Education and Experience:
* Bachelor's degree in a Science-related field is required.
* Minimum 3 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
* Strong background in Chemistry and Analytical testing is essential.
* Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products is necessary.
* Knowledge of analytical techniques such as Compendial testing would be advantageous.