Job Description

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 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.
* 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 1-2 years of Quality Assurance experience preferred.
* Knowledge of Laboratory or Equipment Validation Experience is required.
* An equivalent combination of education and experience can be substituted.
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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.

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.