Senior Associate Quality Control
We are seeking a highly skilled Senior Associate Quality Control professional to join our team at an award-winning Pharmaceutical organization based in Dublin. This is an excellent opportunity for individuals looking to work with a leading multinational that excels in its industry.
Duties:
* Plan and perform analyses with great efficiency and accuracy.
* Develop and implement multiple complex routine and non-routine methods and procedures, as well as a large variety of assays.
* Report, evaluate, back up/archive, trend, and approve analytical data.
* Troubleshoot, solve problems, and communicate effectively 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 laboratory investigations as necessary.
* Evaluate laboratory practices for compliance on a continuous basis.
* Approve laboratory results.
* Interact with external resources.
* C coordinate LIMS data for commercial and import testing on site where applicable.
* Represent the department/organization on various teams and may 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 desirable.
* Experience with analytical techniques such as Compendial testing would be advantageous.