Website Lenox Executive Search
6 months to start with the possibility of extension
• Support Quality Compliance activities associated with Commercial cGMP biologics drug substance operations through internal/regulatory body audits, document review and interactions with site personnel.
• Support site personnel performing deviation investigations, CAPAs and change controls through knowledge of quality concepts, investigational techniques and root cause analysis.
• Regularly work cross-functionally with other departments and may also interact with other company sites and/or Brooklyn Park suppliers to ensure global compliance and consistency.
• Support application of quality compliance by aligning daily responsibilities with the appropriate cGMP regulations for US, EU and Japan.
• Support analyses of manufacturing-related quality metrics to identify risks, improvement opportunities and/or compliance concerns. Support resolutions to conclusion by supporting continuous improvement initiatives.
• Support logistic activities related to the Quality Self-Assessment program and execute assessments with guidance from Quality Compliance management.
• QA support on corrective actions resulting from self-assessments or inspection readiness activities.
• Support during all internal or regulatory audits/inspections of Quality & Operations departments.
• Perform weekly monitoring and updates to quality systems for any adverse compliance trends and escalate any risks to manager.
• May identify regulatory issues and trends and escalate to manager, as appropriate.
• Receives minimal supervision on routine work assignments. Receives specific instruction on new work.
• Complete mandatory training within required timeframe.
• Additional tasks and duties as assigned.
• Bachelor’s degree in Life Sciences and 3-5 years’ experience in a regulated industry preferred.
• Master’s degree in Life Sciences with 0-2 years’ experience in a regulated industry a plus.
• Knowledge of cGMP regulations for US, EU and other markets.
• Must be detail-oriented and have effective time management skills.,.
• Excellent interpersonal skills and the ability to work effectively and efficiently in a team environment.
• Must be able to clearly and effectively present to all levels of the organization
• Excellent organizational skills
• Proficient computer, verbal and written communication skills.
• Strong problem solving and data analysis skills.
• Drives results