Senior Associate – QC Responsibilities 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 applicableMay represent the department/organization on various teams. May train others. QualificationsBachelor’s degree in a Science related field is required. 3+ 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. Experience with analytical techniques such as Compendial testing would also be advantageous
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