Quality Control Manager
Olon Ricerca Bioscience
Quality Control Specialist
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 materials
Streamline current processes and procedures to provide consistent, timely performance
Review and approve certificates of analysis received from contract laboratories
Review and approve deviations related to QC activities
Review OOS and OOT Investigations
Support audits of contract laboratories in cooperation with Quality Assurance
Review 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 product
Assist with preparation and review of regulatory filings
Assist with preparation, review and approval of APRs
Create, edit, review and approve SOPs
Minimum of 7 years of experience in the pharmaceutical industry and quality systems
Minimum of 3 years of QC laboratory experience
Bachelor's Degree in life sciences, preferably chemistry
Experience in regulated manufacturing environments including regulatory authority inspections
Strong written and verbal communication skills
Demonstrated experience in structured process improvement
Experience performing oversight and audits of laboratories
Experience reviewing and approving raw data, test results and certificates of analysis for raw materials, drug product intermediates and final product
Experience reviewing and approving method transfer and method validation protocols and reports
Vacancy posted 2 days ago
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