Quality Control Professional
This is an exciting opportunity to work with a Pharmaceutical organization.
The ideal candidate will have a Bachelor's degree in a Science related field and 3+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
* 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.
* Conduct regulatory filings.
* Investigate lab issues 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. May train others.