Supervisor, Quality Assurance Shop Floor (Wednesday-Saturday First Shift) CAR T at (BMS) Bristol-Myers Squibb in Summit, New Jersey

Posted in General Business 11 days ago.

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Type: Full-Time





Job Description:

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

 

Join us and make a difference.  We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

The Supervisor is responsible for providing quality oversight for the QA shop floor program in accordance with BMS policies, standards, procedures and Global cGMP.  Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with QA Shop Floor Specialists/Senior Specialists and Manufacturing Operations Associates to resolve manufacturing issues.

REQUIRED COMPETENCIES:  Knowledge, Skills, and Abilities:


  • Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance.

  • Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.

  • Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.

  • Must possess an independent mindset.

  • Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.

  • Work is self-directed.

  • Confident in making decisions for non-routine issues.

  • Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues. Develops procedures.

  • Proposes solutions for complex issues and works with management to resolve.   Follows established procedures and performs work as assigned.

  • Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.

  • Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.

  • Is recognized Subject Matter Expert within the group.

  • Provides guidance to other employees in interpretation of complex data.

  • Understands continuous improvement and improves efficiency and productivity within the group or project.

  • Builds relationships internally within and with cross functional teams.

  • Contributes to goals within the work group.

  • Able to recognize conflict and notify management with proposed 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.

  • Excellent verbal and written communication skills.

Education and Experience:


  • Relevant college or university degree preferred.

  • Minimum 5 years of relevant Quality Assurance work experience, with a minimum of 3 years’ experience in a GMP aseptic, manufacturing environment, required.

  • Minimum 1 year of Managerial/Leadership experience is required.

  • Equivalent combination of education and experience acceptable.

Duties and Responsibilities:


  • Provide oversight of QA shop floor program.

  • Ensure manufacturing compliance with applicable procedures and batch records.

  • Perform real time review of manufacturing batch records.

  • Review manufacturing shop floor documentation.

  • Issue production batch records and product labels to Operations.

  • 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.

Working Conditions (US Only):

Work is performed in a combination of manufacturing and office environments, with manufacturing and standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 50% of the time, in a mixed environment of office areas and cleanroom suites (in cleanroom gowning). Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

The First Shift hours for this position are 6:30AM-5:00PM.

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Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.