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Associate Project Manager Resume

Jessup, PA

SUMMARY:

Goal - driven and detail-oriented professional with extensive experience in quality assurance, quality system and supplier auditing, and supply chain management in the medical device industry. Effective in identifying, analyzing, and mitigating risks; analyzing contracts and value; and performing both internal and external audits. Equipped with articulate communication and interpersonal skills in building positive work relationships with clients and professionals of all levels.

TECHNICAL SKILLS:

Microsoft Office (Excel, PowerPoint, Project, and Visio) Internal SAP system (QAD) Internal Document Control System (Master Control) SharePoint Application

PROFESSIONAL EXPERIENCE:

Confidential, Jessup, PA

Associate Project Manager

Responsibilities:

  • Keenly review product documentation to ensure compliance with internal procedures and statutory requirements
  • Collaborate with Regulatory Affairs and Quality Assurance to guarantee compliance of assigned projects 
  • Lead the conceptualization, development, management, implementation, reporting, and maintenance of project plans
  • Supervised project team meetings to communicate routine project updates and meeting minutes
  • Establish timelines, milestones, risk mitigation strategies, and goals for assigned projects
  • Contribute to the implementation of corporate-wide systems, procedures, and structures that provide efficient project management
  • Take charge of sourcing, procuring, managing, and maintaining inventory for various raw materials, ensuring consistent and improved quality while achieving significant cost savings across the foundation
  • Manage, maintain, and monitor all supply chain facets of MTF production lines, including Cascade Autologous Platelet System, Lipografter, and Mesobiomatrix
  • Act as the department representative on several teams, tasked with the following corporate goals and initiatives:
  • Multiple product line launches
  • Supplier assessments, risk assessments, and qualifications
  • Conducted Investigations, root cause analysis, disposition, and closure with Nonconformance Teams

Associate Manager

Confidential

Responsibilities:

  • Participated in inventory valuation and reductions to maintain cost-effective levels while achieving optimum production levels
  • Supervised the activities of the Strategic Supplier Monitoring Program to ensure supplier and quality compliance, which included conducting supplier risk assessments
  • Directed several teams and departments, including supply chain specialists, Central Supply Packaging, and Material handling and Receiving
  • Provided leadership to contract management and material management to guarantee outstanding support and service for operations in accordance
  • Managed supply chain cost saving initiatives related to labor, distribution, and use of raw materials
  • Handled the negotiation of strategic supply and quality agreements as required, including nondisclosure, joint development, intellectual property, and other agreements to ensure positive relationships with a base of critical and key supplier partners

Supply Chain Management Specialist

Confidential

Responsibilities:

  • Served as part of the Supplier Quality Management Team in providing supplier performance analysis
  • Collaborated with business unit leaders during the budgetary process through material data collection, as well as tracking and trending budget items in real time to better position the business unit’s needs and cost allocations
  • Contributed to the negotiation, oversight, and management of supplier contracts and agreements to ascertain legal and financial compliance, and implemented performance criteria based on customer and supplier requirements
  • Partnered with Research and Development, Process and Quality Engineering, and Operations on projects that connected to new tissue commercialization requiring material, chemical needs, or solutions
  • Rendered support to value analysis programs to determine opportunities for cost efficiencies related to product, service, and process standardization and utilization
  • Functioned as part of the Material Review Board, which entailed reviewing potential new raw materials for quality and supply chain requirements to ensure compliance with internal and external procedures and regulations

Quality Assurance Auditor

Confidential

Responsibilities:

  • Organized, initiated, reported, and followed up on audits on internal operations, suppliers, and external organizations to guarantee procedural, contractual, standard, and regulatory compliance
  • Generated reports on audits, trend analysis, non-conformances, and complaints to management to support decision-making processes
  • Function as the foundation’s representative on all regulatory audits performed by regulatory bodies, including FDA, ISO, international regulatory bodies, business partners, and state regulatory units
  • Acted as the CAPA coordinator in managing adverse event reporting, CAPA actions, and recalls, which included database and file controls, investigation, reporting, regulatory notification, customer interface, corrective action, and follow up
  • Facilitated training on quality assurance and regulatory affair topics

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