Alyson Ducos

• Established, maintained, and enforced organizational standards of performance, quality, and safety compliance.
• Collaborated with other managers across the organization to develop strategies that support overall company objectives.
• Conducted regular audits of employee performance and provided feedback on areas of improvement.
• Coordinated training sessions for new employees regarding company policies, procedures as well as job roles, responsibilities associated with their positions.
• Drafted final audit reports outlining findings, conclusions, observations and recommendations.
• Monitored production processes to ensure quality standards were met and documented results of inspections.

• Directed day-to-day operations by spearheading implementation of short-term and long-term strategies to achieve business plan and profitability goals.
• Managed scheduling, training and inventory control.
• Implemented policies and standard operating procedures and managed quality, customer service and logistics.
• Improved morale and management communication by creating employee recognition and rewards practices.
• Recruited, hired and trained crew members on Standard Operating Procedures.
• Measured and reviewed performance via metrics.
• Identified areas of deficiency and performed root-cause analysis to solve problems.
• Supported other sites on projects and daily basis operations.
• As the radiation Safety officer, in charges of lab's radiation safety program. Ensured staff was properly trained and lab was in compliance with OSHA, NRC and DOT.
• Coached, mentored and trained team members in order to improve their job performance.

• Monitored QA procedures for adherence by employees, notifying personnel of non-compliance issues.
• Maintained compliance with company and regulatory policies.
• Coordinated and supported on-suite audits conducted by regulatory bodies.
• Worked with on-site teams to complete timely tests and facilitate smooth product releases.

Responsible for operational excellence, developing and implementing quality control policies and procedures to ensure finished goods comply with regulatory standards and product specifications.

· Manufacturing of sterile injectable nuclear drug products under FDA current Good Manufacturing Practices (cGMP) guidelines (eg, operations, routine validation, corrective and preventive action [CAPA], batch release).

· Provided QA support for gap/risk analysis for Tech Transfer for new build out.

· Responsible for providing QA support for site Supplier Remediation: Supplier Change Notifications, New Material Requests and SCAR reports, ASL.

· Managed and ensured site cGMP compliance as per the current regulations.

· Overall responsibilities included document management and control (SOPs/ change controls/ deviation investigations/ CAPAs), Raw Material Release, Oversight of Qualification/Validation Activities (facility, critical utilities, and equipment), ensuring GMP and GLP compliance.

· Responsible for ongoing development and improvement of the Quality Management System.

· Revise and generate new and existing Standard Operating Procedures (SOP’s), test reports and quality of standard for the compound product.

Projects: Vizamyl Expansion; responsible for training two to three operators in person at their PET site to manufacturer and quality control test General Electric’s Vizamyl injectable drug.