Bristol Myers Squibb Company

QA Specialist Batch Record Review

Location
Summit West, NJ, United States
Posted
Sep 15, 2020
Ref
R1529675
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.

Location:

Summit West, S-12

About Bristol-Myers Squibb

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.

PURPOSE AND SCOPE OF POSITION:

The QA Specialist is responsible for performing accurate and timely maintenance review of the quality records used at the CAR T manufacturing and testing facilities in accordance with policies, standards, procedures and Global cGMPs.

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.
  • 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.
  • Understands continuous improvement and improves efficiency and productivity within the group or project.
  • 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:
  • Bachelor's degree with minimum of 2 years of relevant work experience
  • Preferred experience in biopharmaceutical Quality Assurance, Clinical, Supply Chain, Manufacturing, and Commercialization
  • An equivalent combination of education and experience may substitute.


DUTIES AND RESPONSIBILITIES:
  • Review and approval of executed batch records.
  • Issue production batch records and product labels to Operations.
  • 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.
  • Responsible for initiating deviations, performing investigations, CAPA implementation and continuous improvement of QA material release standard operating procedures.
  • Ensure all investigations, CAPAs and change controls are completed in a timely manner.
  • Must be skilled in planning and organizing, decision-making, and building relationships.
  • Support QA during audits and site inspections for QA compliance related inquiries.
  • Able to effectively multi-task.
  • Performs other duties as assigned.


WORKING CONDITIONS (US Only):

Work is generally performed on-site seated, but may require standing and walking for up to 10% of the time. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management based on business needs.

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.