Quality Assurance Specialist III

  • location: Lexington, MA
  • type: Contract
  • salary: $44.04 - $51.82 per hour
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job description

Quality Assurance Specialist III

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!

location: Lexington, Massachusetts
job type: Contract
salary: $44.04 - 51.82 per hour
work hours: 9 to 5
education: Bachelors
  • Driving the execution of the global Supplier Quality and Material Management programs
  • Execution of qualification, maintenance and monitoring for the supplier base in her/his region, with an emphasis on continuous improvement, global alignment, risk management and supply chain reliability
  • Partners with the business and key stakeholders to drive continuous improvement in Quality performance across the company, to understand priorities, align on expectations
  • Supporting global cross functional stakeholders on matters pertaining to supplier controls, significant concerns related to Quality System performance, risk-based audit execution, issue escalation, procurement strategy and regulatory compliance
  • Execution of global supplier and material/product management and audit activities within assigned category and geographical regions including:

    • Building relationships with global / critical / key suppliers
    • Creation and maintenance of global product / material specifications
    • Solving of material related issues in cooperation with impacted facilities and suppliers resp. manufacturers around the globe (Material Deviations, CAPAs)
    • Supplier Qualification and maintenance / Quality Agreements
    • Supplier Audits
    • Evaluation and Execution of Supplier Notification of Changes
    • Managing change controls e.g. due to necessary product/material specification changes
    • Supplier Monitoring
  • Support the maintenance of an environment of teamwork and collaboration
  • Execute the strategic direction and oversight pertaining to external auditing and supplier quality and material management achieves sustained success for regulatory inspections and supply chain product quality
  • Support the preparation and the maintenance of global audit and specification policies, guidance, standards, procedures governing Quality Auditing and Supplier Quality and ensures staff comply with the documents
  • Support the coordination with Site QA auditors, Supplier Quality management groups and global audit planning / scheduling group to assign lead auditors and co-auditors within region to perform audits according to annual (fiscal year) audit plan
  • Promptly escalate and report all critical audit findings, critical material issues and supplier performance incidents to the appropriate persons
  • Perform internal/external audits as needed (up to 50 % travel time due to audits)
  • Support Due Diligence activities worldwide providing subject matter expertise to enable decision making; identifying quality related risks to projects and the provision of appropriate resolutions
  • Executes the Supplier Qualification and Product/Material Specification program requirements per schedule
  • Provides performance metrics to drive continuous improvement of the programs
  • A member of the Quality Auditing and Supplier Quality team
  • Ad-hoc participation with Quality Auditing and Supplier Quality LST as needed
  • Responsible for performance management and risk identification for suppliers and resolution of incidents
  • Interaction (The span and nature of one's engagement with others when performing one's job, internal and external relationships)
  • Quality Auditing and Supplier Quality organization
  • Alignment with SBO partner for Strategy, Global project management, Change Management,
  • Alignment and partner with Global Quality Compliance for Knowledge Management and community of practices
  • Partner with Procurement on Supplier Quality Management processes and individual supplier
  • Partner with global Manufacturing Sciences Quality
  • Partner with Operating units to support business priorities from a supplier quality perspective
  • Interacts on a routine basis with external business partners and suppliers
  • Scientific degree (BSc, MSc)
  • 1-2+ years of increasing management responsibility combined with deep knowledge of biopharmaceutical manufacturing
  • Some Experience about Quality pillars (QA, QC, Systems and Compliance, Services and Improvement) including global cGMP regulations (US, EU, Japan, Canada, etc.)
  • Some Experience working with regulatory agencies and/or direct interface experience with regulatory agencies during inspections highly desirable/preferred.
  • Fluent in written and spoken English
  • Knowledge and experience of Bio-Pharmaceutical, R&D and Vaccines Manufacturing
  • Knowledge and understanding of all therapeutic areas as well as scientific advances and modalities for treating diseases.
  • Knowledge and understanding of relevant regulations enabling effective partnerships across the organization
  • Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)
  • Demonstrated sound judgment. Must be confident, resourceful, self-reliant and self-motivated.
  • Prioritizes and manages time effectively to reliably meet timelines
  • Open for changes.
  • Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)
  • Critical thinking, analytical, and problem solving skills
  • Understanding of local and global regulations
  • Communication skills engaging stakeholders: site, business, network, company, regulators.
  • Courage of conviction and conflict resolution skills.
  • Risk identification, evaluation and management
  • Continuous improvement
  • Personal accountability for results and integrity
  • Ability to present key quality/department/business concepts to senior representatives of external business partners and internal senior leadership teams.
  • Strong PC skills and be competent in Word, Excel, PowerPoint and SharePoint
  • Leadership Behaviors
  • Demonstrates effectiveness in task completion, decision-making, training and problem-solving
  • Focusing on the few priorities and provide superior results
  • Elevating capabilities for now and the future
  • Team player
  • Ability to drive change
skills: SOP, Quality Assurance, MS-WORD, CAPA, MS-EXCEL, MS-Powerpoint, Regulatory Affairs Operations, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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