Job Responsibilities:

Support QC functions related to GXP activities (e.g., cGMP manufacture of clinical and commercial active pharmaceutical ingredients)Manage laboratories that perform finished product testing of clinical and commercial materialsStreamline current processes and procedures to provide consistent, timely performanceReview and approve certificates of analysis received from contract laboratoriesReview and approve deviations related to QC activitiesReview OOS and OOT InvestigationsSupport audits of contract laboratories in cooperation with Quality AssuranceReview raw materials, in process and finished product specifications (purchasing, release and stability)Perform trend analysis of testing data to establish purchasing and release specifications for in process and finished productAssist with preparation and review of regulatory filingsAssist with preparation, review and approval of APRsCreate, edit, review and approve

SOPsQualifications:

Minimum of 7 years of experience in the pharmaceutical industry and quality systemsMinimum of 3 years of QC laboratory experienceBachelor's Degree in life sciences, preferably chemistryExperience in regulated manufacturing environments including regulatory authority inspectionsStrong written and verbal communication skillsDemonstrated experience in structured process improvementExperience performing oversight and audits of laboratoriesExperience reviewing and approving raw data, test results and certificates of analysis for raw materials, drug product intermediates and final productExperience reviewing and approving method transfer and method validation protocols and reports