Bristol Myers Squibb Company

Senior Specialist, Quality Assurance Engineering Cell Therapy

Location
Celgene, NJ, United States
Posted
Sep 09, 2020
Ref
R1525284
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 Quality E- Systems Senior Specialist's primary responsibility is to help assure the quality, integrity, and compliance of site Information Technology (IT) systems, and maintain alignment between business process owners, end users, and other cross functional areas. Altogether, the Senior Specialist will help ensure that IT systems are designed, setup, and function in a GMP-compliant manner which, in turn, will assist the site in safeguarding and maintaining the safety and quality of Bristol Myers Squibb's products.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
  • Advanced knowledge of GMP guidance and regulations, including those pertaining to
    computerized system design, function, and use.
  • Advanced knowledge of electronic batch records, Microsoft Word, Outlook, and Excel.
  • Requires ability to communicate appropriately with regulatory agencies.
  • Intermediate written and verbal communication skills.
  • Intermediate problem-solving, critical-reasoning, and decision-making skills.
  • Intermediate time-management, organizational, and multi-tasking abilities.
  • Ability to work independently for extended periods of time.
  • Ability to interpret / write technical documents.
  • Ability to solve routine and complex problems.
  • Quality Compliance systems experience highly preferred
  • Strong knowledge of GMP Regulations required
  • Knowledge of CFR 21 Part 11 is a plus.


DUTIES AND RESPONSIBILITIES:
  • Provides input and quality approvals for validation documentation that supports enterprise systems or applicable site and/or globally owned systems.
  • Drives use of best-practices during IT systems design, validation, and use.
  • Coordinate with IT and other site departments to maintain and support electronic systems that are compliant, efficient, effective and reliable.
  • Collaborates with business stakeholders, technical support groups and Quality Assurance (as needed) to thoroughly investigate validation or engineering discrepancies.
  • Ensures all required system documentation is maintained as changes in the system(s) are made. Documentation includes, but not limited to functional requirements, user requirements, and design specifications.
  • Reviews and approves documents, change controls, and protocols related to IT systems (site and global).
  • Applies data integrity regulations and guidance from governing agencies when participating in site and global projects related to computerized systems.
  • Supports deviations as needed.
  • Represents and leads Quality Assurance Operations for CAR T through the initiation and implementation of projects related to electronic systems.
  • Manages project activities and ensures appropriate team members are assigned to appropriate activities.
  • Supports continual alignment of the business process with other business functions and provide effective on-going end user support.
  • Develops, maintains and improves key business processes.
  • Provide training to appropriate end users as related to enterprise system implementation and updates.
  • Drafts, reviews, and edits SOPs, process flow and other business documentation.


EDUCATION AND EXPERIENCE:

Bachelor of Science degree required, with a minimum of five years of related Quality, Manufacturing, and Compliance experience in the pharmaceutical industry

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.