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Shop Floor Quality Assurance Cell Therapy, 6a, 6p
Posted on 7/20/2022
Devens, MA, USA
Experience Level
Desired Skills
  • High School Degree required
  • Relevant college or university degree preferred
  • Minimum 6+ years relevant work experience, with at least 3 years in a Quality Assurance role
  • Equivalent combination of education and experience acceptable
  • Previous Supervisory/Managerial Experience is preferred
  • Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking
  • Understands continuous improvement and improves efficiency and productivity within the group or project
  • Builds relationships internally within and with cross functional teams
  • Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments. Prefer to also have knowledge of GMP Manufacturing operations and processes
  • Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies
  • Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues
  • Able to recognize conflict and notify management with proposed recommendations for resolution
  • Must possess an independent mindset. Work is self-directed
  • Requires little direction to complete more complex tasks; completes routine tasks with little or no supervision
  • Able to provide directions to others within the team
  • Confident in making decisions for non-routine issues
  • Develops and revises procedures
  • Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution
  • Able to prepare written communications and communicate problems to management with clarity and accuracy
  • Able to effectively multi-task
  • Knowledge of US and global cGMP requirements
  • Able to lift up-to 25 pounds several times a day
  • Able to stand and walk for several hours at a time in a 12-hour shift
  • Able to move between rooms in a timely manner
  • Able to work near strong magnetic fields
  • Able to gown for ISO 8 and ISO 7 rooms (medical scrubs, safety shoes, safety glasses, gloves, coveralls, booties, etc.)
  • Oversee performance of QA shop floor activities
  • Ensure manufacturing compliance with applicable procedures and batch records
  • Perform real time review of manufacturing batch records
  • Review manufacturing shop floor documentation
  • Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles
  • Must be skilled in planning and organizing, decision-making, and building relationships
  • Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management
Bristol-Myers Squibb

10,001+ employees

Biopharmaceutical development company
Company mission
Bristol-Myers Squibb engages in the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceuticals.