Team player offering dynamic personality and strengths in cultivating relationships with clients. Organized and motivated employee eager to apply time management and organizational skills in various environments. Seeking entry-level opportunities to expand skills while facilitating company growth. Flexible hard worker ready to learn and contribute to team success.
• Lead all product complaint investigations (critical and non-critical) with minimal guidance and ensure investigation action plans and final investigation summaries are accurate, include appropriate corrective actions, and follow company standards. Collaborate with departments (e.g. Affiliates, Manufacturing/Packaging Sites, External Quality) to establish appropriate, efficient, and timely.investigation strategies.
• Lead root cause analysis and present at QRB.
• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.
• Develop solutions to complex product complaint issues and Quality initiatives with inter-organizational impact following cGMP regulations and Genentech standards.
• Ensure appropriate application & integration of cGMPs in the product complaints management system.
• Draft personal performance accountabilities and provide input to departmental objectives.
• Draft personal development plan and work with department manager to determine development activities for the calendar year.
• Establish work priorities to meet targets and timelines and effectively manage competing priorities, with minimal escalation.
• Serve as the Quality representative on cross-functional and.multi-site teams.
• Identify, design, and implement department or cross-functional business process improvements.
• Analyze complaint information and identify potential Quality issues including performing trend analysis.
Collaborate with key stakeholders to foster effective interdepartmental and cross-functional partnership solutions.
• Develop, train, and mentor personnel and internal customers on relevant business processes.
• Collaborate and influence department procedures (e.g. SOPs, FNs, etc ...).
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Inform management of critical product complaints and provide timelY impact assessments of potentially affected products, materials or processes.
• Review and approve product complaint investigation reports and supporting documentation.
• Educate departments on the best practices for conducting investigations and root cause analysis.
• Lead department project teams to resolve product complaint process deficiencies identified.
• Assess the accuracy of root cause determinations based on a thorough evaluation of possible failure modes.
• Present product complaint records and/or reports during periodic audits and regulatory inspections.
• Perform receipt, sample handling evaluations and testing, including potential biohazardous and cytotoxic materials.
• Communicate with patients and Health Care professionals.
• Perform any other tasks as requested by Management to support Quality oversight activities
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