bb7 is looking for a Senior Quality Engineer to work with our client, a global specialty biopharmaceutical company, and act as the Quality Engineering subject matter expert for assigned products/areas. This position is responsible for collaborating with contract manufacturer and various internal departments to ensure continuous improvement and implementation of identified projects/systems.

Responsibilities

  • Champion specific product lines for compliance from raw material to packaged products
  • Actively participate and drive improvement activities
  • Assure deployment of appropriate validation planning and robust design transfer
  • Apply subject matter expertise in process excellence, six sigma and CQE tools
  • Review, evaluate and endorse investigation documentation for incidents and deviations
  • Provide quality assurance support to manufacturing departments
  • Evaluate and update existing SOPs for cGMP compliance
  • Facilitate, coordinate and champion investigations
  • Perform and participate in MRB investigations
  • Participate in and perform internal cGMP audits
  • Communicate and determine disposition for quality issues within the facility
  • Participate in the annual product review report process
  • Develop and maintain metrics/trending for incidents, deviations and CAPA items
  • Assist in the application of appropriate quality technology tools to establish and maintain process capability and to resolve deviations and non-conformances

Qualifications

  • Bachelor’s degree in a related technical field
  • 5-10 years of quality assurance or engineering experience in medical device or pharmaceuticals
  • Minimum of 3 years’ experience in a cGMP and/or other manufacturing environment
  • Experience including but not limited to the following:
    • Quality and regulatory aspect of manufacturing
    • Validation and design control
    • Data acquisition and statistical techniques
    • Investigations and root cause analysis
    • CAPA and NC
    • Lean six sigma tools
    • Strong computer skills including MS Office and Minitab
    • Strong facilitation and presentation skills
    • Ability to appropriately plan, organize and prioritize work
    • Excellent technical and compliance based writing skills
  • Preferred Skills/Qualifications
    • Ability to apply technical expertise to work and has working knowledge of related functions
    • Ability to work independently with minimal oversight

bb7 offers a culture that values its talented staff members and rewards creativity. We understand that the quality of our staff’s lives is reflected in the quality of their work.

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bb7 and its Clients are equal opportunity employers and do not discriminate in employment on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, veteran status, marital status, disability, age, membership in an employee organization, or any other classification protected by federal, state, or local law. We participate in E-Verify.