Ensures product quality is maintained atstandards set forth by the company's quality systems and as mandated byregulatory agencies. The focus areas for the Quality Control Manager include,but are not limited to: scheduling and executing inspection, testing, anddocumentation of all products manufactured by the company at the Mountain Viewfacility.
· Hire, develop, train, and evaluate QCpersonnel.
· Supervise and oversee QC personnel in theirrole for safe and efficient verification, approval, release/disposition of PCTor client products/materials.
· Ensure and promote compliance with applicableCGMP and GTP regulations and company and client SOPs.
· Work with colleagues in the Allendalefacility to assure alignment and continuity in laboratory practice betweensites.
· Assist in investigation and root causeanalysis and oversee timely closure of deviation reports and applicable batchrecords,
· Ensure completion and oversee review of QClogs.
· Ensure completion of all client QCrequirements related to GMP cellular product and/or material.
· Maintain good client relationships.
· Oversee QC role in material disposition viadeviation reporting system or client based system if applicable.
· Prioritize, schedule and manage multipleprojects and resources simultaneously.
· Monitor effectiveness of quality systems,change control activities and completion both facility and client specific.
· Evaluate and investigate customer complaintsand deviations; initiate and coordinate corrective and preventive actions asthey relate to the quality control function or as assigned.
· Maintain tracking and trending aspects of thedeviation reporting system.
· With colleagues in the Allendale facility,develop and maintain Key Performance Metrics (KPI) for laboratory testing andevaluation.
· Interface with suppliers and in-houseproduction personnel to ensure effective corrective and preventive actions areimplemented for recurring product/process discrepancies as applicable.
· Interface with operation’s management andupper management in significant deviation resolution and corrective actionimplementation.
· Develop, revise and implement StandardOperating Procedures as related to Quality Control activities.
· Complete projects and special tasks asassigned.
Knowledge and Experience
· BS degree in biological sciences orequivalent.
· Minimum 5 years related experience in thepharmaceutical, biologics or related industry.
· Proven ability to lead, coach, and motivateemployees, clearly communicate job requirements and effectively manageperformance of assigned staff with a minimum of three years in a managementposition.
· Understanding of current Good ManufacturingPractices (cGMPs)
· Working knowledge of routine QC laboratoryprocedures such as flow cytometry and CBC analysis, endotoxin testing,equipment and systems, an understanding of production processes andvalidation.
· Sound knowledge of aseptic processing andsupporting technologies.
· At least 3 years experience with writing,reviewing and following Standard Operating Procedures.
· Analytical and technical troubleshootingskills
· Excellent organizational skills and attentionto detail.
· Good verbal and written communicationskills.
· Strong team-oriented interpersonal skills areessential.
· Travel may be required.