Senior Specialist, QA Shop Floor
2 weeks ago
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
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.
The Sr. Specialist QA Shop Floor overseeing quality activities of the QA shop floor program in accordance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues.
Shift Available:
Monday - Friday, Onsite Day Shift, 9 a.m. - 5:00 p.m.
Responsibilities:
Build and maintain relationships with Manufacturing Operations, Quality Control, MSS-PMO, Materials Management, Manufacturing Science & Technology, and other departments to effectively accomplish responsibilities make improvements and resolve issues.
Ensure manufacturing, QC, and warehouse compliance with applicable procedures and batch records.
Conduct Quality on the Floor activities including quality walk-throughs of the production, testing and warehouse locations.
Oversee Apheresis, PBMC and CMAT receiving and Cryopreserved Drug Product.
Review executed records for documentation completeness and accuracy per ALCOA+.
Support quality processes, including material disposition, material storage and handling requirements, change controls, product complaints, deviations, investigations, and CAPA management.
Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
Must be skilled in planning and organizing, decision-making, and building relationships.
Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
Must be able to work in the cleanroom environment for 6-hour time periods.
Must be flexible for shift hour changes to support manufacturing.
Additional Qualifications/Responsibilities
Knowledge & Skills:
Must have sound knowledge and experience in FDA regulated cGMP Quality Manufacturing operations and processes.
Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
Must possess an independent mindset.
Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
Work is self-directed.
Confident in making decisions for non-routine issues.
Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.
Develops procedures.
Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned.
Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
Basic Requirements:
Relevant college or university degree preferred. An equivalent combination of education and experience will be considered.
A minimum 4 years of relevant experience within Quality Assurance within a manufacturing GMP facility.
A minimum of 2 years hands-on experience in QMS.
A minimum of 2 years of experience with risk assessments.
1 year of deviation experience.
Strong project management experience.
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