Senior QC Associate
- Dublin
- Contract
- Full-time
- Plan and perform analyses with great efficiency and accuracy.
- Plan and perform multiple, complex routine/ non-routine methods and procedures and a large 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 that may be departmental or organizational in scope.
- Review protocols and perform assay validation and equipment qualification/ verifications when required.
- Introduce new techniques to the lab, including method transfers, reports, validations, and protocols.
- May contribute to regulatory filings.
- May conduct lab investigations as necessary.
- Evaluate lab practices for compliance on a continuous basis.
- Approve lab results.
- May interact with outside resources.
- LIMS data coordination of commercial and import testing on site where applicable.
- May represent the department/organization on various teams.
- May train others.
- Bachelor’s degree in a Science related field is required.
- 4+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.