Bristol Myers Squibb Company

Supervisor, Aseptic Quality Assurance Shop Floor Wednesday-Saturday 1st Shift Cell Therapy

Location
Celgene, NJ, United States
Posted
Aug 28, 2020
Ref
R1527181
Required Education
Bachelors Degree
Position Type
Full time
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

PURPOSE AND SCOPE OF POSITION:

The Supervisor is responsible for providing quality oversight for the QA shop floor program in accordance withBMS 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 operations to resolve manufacturing issues. The Shift Hours for this position are Wednesday through Saturday, 6:30AM-5:00PM.

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.


BMSCART

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.