Senior Specialist, Quality Assurance Engineering

Location
Summit West, NJ, United States
Posted
Sep 29, 2020
Ref
R1530250
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.

Position Title:

Senior Specialist, QA Engineering

Direct Manager:

Associate Manager, Quality Assurance Engineering

Division:

CTDO Quality Assurance

Grade:

D05

Direct Reports:

N/A

Location:

Summit West, S12

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 Senior Specialist is responsible for providing quality oversight for Site Validation activities and Quality Control Laboratory method and equipment validation in accordance with Celgene policies, standards, procedures and Global cGMP. Functional responsibilities for the incumbent include ensuring accurate and timely maintenance and review of validation and qualification documents for all equipment and facility activities; support data integrity initiatives for the site.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
  • Must have GMP, Quality, and in-depth risk management knowledge.
  • Must be able to recognize and group technical/scientific attributes and drive science-based decisions in most technical areas and to a deeper level in the specific job function.
  • Must manage development of technical or scientific initiatives and activities by interdisciplinary teams.
  • Must have strong authorship and be able to critically review investigations and reports, interpret results, and generate technical conclusions consistent with Quality risk management principles.
  • Must be able to recognize patterns and trends in reported data and communicate strategic solutions to stakeholders cross-functionally.
  • Requires minimal direction to completes tasks, knows how to get resources and information from established internal contacts; consults with supervisor for decisions outside established processes; manages experienced professional employees; authority to make daily decisions that impact their team.
  • Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams
  • Routinely recognizes and resolves Quality issues; informs management of proposed solutions. Seeks management guidance on complex issues; develops procedures.
  • Able to fully interpret complex results and situations with degree of independence and articulate recommendations for solutions. Recognizes risk and develops contingency plans. Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and productivity within the group or project.


Education and Experience:

*Bachelor of Science degree required

*Minimum of five (5) years of experience in the pharmaceutical or related industry.

DUTIES AND RESPONSIBILITIES:
  • Supports all activities for the Quality Engineering group.
  • Support the Qualification and Validation activities in relation to QC and manufacturing equipment and facility design.
  • Assures appropriateness of calibration/maintenance programs, validation plans, qualification protocols, associated reports and procedures.
  • Ensure compliance with the site validation master plan, assist with facility start-up operations and product transfers supporting the Qualification and Validation teams.
  • Review media simulation activities to ensure successful execution and documentation.
  • Ensure site is compliant with global and regulatory data governance and data integrity requirements.
  • Establishes and maintains procedures to ensure Data Integrity is maintained and procedures/processes are compliant.
  • Work with laboratory management to ensure laboratory activities comply with global regulatory requirements.
  • Ensure method qualifications, method transfers, and analyst trainings meet company and regulatory requirements.


WORKING CONDITIONS (US Only):

Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

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.

If you want to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients' lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.

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.