Manager, Quality Control Equipment - Summit, NJ

Job Description

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Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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.

At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.

As our Manager, QC Equipment, you would be responsible for the monitoring or trending of calibration and maintenance activities for all Quality Control equipment in support of the analytical and microbiology CAR T QC laboratories. This includes, but is not limited to, interfacing with SMEs, facilities, and vendors to support equipment maintenance activities, standardizing SOPs, and supporting projects to increase equipment uptime to support commercial operations. This role will also support equipment-based investigations and corrective actions and may serve as a people manager, as needed.

Shift Available :

Monday - Friday, Onsite Day Shift, 8 a.m. - 5 p.m.

Responsibilities :

Create equipment User Requirement, validation protocols and equipment related documents.

Collaborate with QC laboratories, Site Engineering, Facility Services, and other departments for the commissioning and decommissioning of laboratory equipment.

Schedule, facilitate and participate in performing the validation, calibration, maintenance, repairs of QC laboratory equipment, whether performed internally or by vendors.

Maintain equipment records in accordance with GMP requirements and written procedures.

Maintain electronic equipment database, equipment records and logs, equipment status metrics, and apply equipment status labels.

Anticipate and perform routine troubleshooting and problem solving with minimal guidance.

Train and mentor others on equipment lifecycle process and procedures as applicable.

This includes, but is not limited to, interfacing with SMEs, facilities, and vendors to support equipment maintenance activities, standardizing SOPs, and supporting projects to increase equipment uptime to support commercial operations.

Support equipment-based investigations and corrective actions and may serve as a people manager, as needed.

Perform document revision, project, CAPA and deviation / investigation, change management actions, related tasks and / or continuous improvement efforts.

Review GMP documentation / records, including vendor executed validation documents for GDP adherence.

Perform other tasks as required to support the QC laboratories.

Knowledge & Skills :

Function as QC equipment owner / SME :

Responsible for QC activities as it relates to equipment change management.

Collaborate with other departments for commissioning and decommissioning equipment.

Assist management with investigations and deviations related to equipment.

Responsible for the maintenance of equipment logs, equipment status labels, etc.

Function as primary support for equipment troubleshooting :

Perform approvals for relevant equipment activities.

Maintain equipment metrics activities.

Conduct management authority for review and approval activities :

Serve as author or technical reviewer of appropriate departmental procedures.

Review documentation as required by laboratory procedures.

Perform approvals for relevant laboratory activities.

Provide guidance and leadership :

Perform group trainings on QC processes (ie. Logbook use, tagging equipment out of service).

Lead and develops best practices.

Perform other tasks as assigned.

Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.

High problem-solving ability / mentality, technically adept and logical.

Ability to communicate effectively with peers, department management and cross-functional peers about task status, roadblocks and needs.

Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.

Additional Qualifications / Responsibilities

Basic Requirements :

Bachelor's degree or equivalent required, preferably in Science.

6 years of relevant cGMP QC laboratory experience.

1-2 years of leadership experience is required.

Advanced knowledge of LMS / enterprise systems.

3 years of data integrity experience.

Demonstrated technical writing skills.

Demonstrated experience with equipment qualification.