Senior Specialist Quality Assurance Engineering Cell Therapy

Profile

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 BMS 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, laboratory, 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, with a minimum of five years of related Quality Assurance experience in the pharmaceutical industry

Knowledge of Laboratory Validation Experience is required..

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.

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.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com