Senior Specialist, QA Shop Floor M-F, Cell Therapy

About the role

The Quality Assurance Shop Floor team oversees and partners with operational areas to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. This position works a Monday to Friday schedule, Day shift.

Responsibilities

• Provide Quality oversight to Manufacturing/QC/Warehouse/Packout operations.
• Identify departures from approved procedures & respond to complex issues independently & escalate critical issues to management.
• Perform and document operational verification per approved procedures.
• Develop, review and/or approve temporary and non-routine procedures for event response.
• Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques.
• Cookwalk and lead area walkthroughs to identify quality issues.
• Negotiate remediations and drive alignment of implementation plans.
• Own actions for departmental programs and propose improvements to programs.
• Participate in Gemba walks.
• Communicate and resolve discrepancies independently and escalate as required.
• Author, review, and approve procedural documents.
• Maintain compliance with assigned learning plan.
• Provide guidance and training for QA personnel.
• May own training curriculum and content.
• May present individual topics during audits as needed.
• Independently assess discrepancies for entry into quality system and approve deviations as applicable.
• May serve as quality subject matter expert for risk assessments, change controls, etc.
• Lead meetings and represent function at cross-functional meetings.
• Share data/knowledge within and across team.
• Build & maintain strong relationships with partner functions.
• Prioritize and assign tasks for the team.
• Periodically observe operations occurring on the floor and proactively identify risks and drive improvements.
• Establish and maintain key performance indicators and standard work databases in alignment with departmental and product supply goals.
• Functions as a project manager able to influence others based on time and task commitments, organize/run meetings.
• Obtain access to, and develop as an SME for, various electronic systems utilized by Shop Floor Quality (BMSDocs, CELabs, MES, SAP, ValG, DeltaV, Maximo, Infinity, etc.).
• Should be familiar with GMP-related systems including Quality Risk Management, Document and Data Governance, Monitoring and Reporting.
• Share data/knowledge within and across teams by acting as a champion for quality-culture and learning.

  Qualifications & Experience

  • Ability to research, understand, interpret and apply internal SOP’s, policies and regulatory guidelines.
  • Proficient computer skills with knowledge of digital tools such as MS Office, etc. and ability to learn and work with new software applications.
  • Ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions.
  • Excellent written and verbal skills and ability to present technical data effectively based on target audience.
  • Ability to work in a fast-paced team environment and lead peers through changing priorities.
  • Detail oriented and task focused with ability to meet deadlines and support work prioritization.
  • Ability to negotiate and influence to craft mutually beneficial solutions.
  • Ability to motivate and foster a positive team environment.
  • Exhibit strong decision-making ability and think creatively while maintaining compliance and quality.
  • Demonstrated experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management.
  • Demonstrated ability to learn and work with analytical computer/digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc.
  • Bachelor's degree in STEM field preferred. High school diploma/Associates degree with equivalent combination of education and work experience may be considered.
  • 4+ years of relevant cGMP experience, preferably with 1+ year of manufacturing site experience.
  • Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
  • Demonstrated experience with quality management systems.
  • Demonstrated experience in GxP electronic systems such as Quality Management Systems (QMS); Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms.