QA Senior Specialist, Deviation Reviewer and Approver (Mon - Fri)

Working with Us
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. Read more: careers.bms.com/working-with-us.

PURPOSE AND SCOPE OF POSITION:

This role will be responsible for providing oversight for deviations and investigations for manufacturing operations and quality control laboratory operations at the Summit S12 Cell Therapy manufacturing facility, in accordance with Bristol Myers Squibb policies, standards, procedures and Global cGMP. Functional responsibilities for the incumbent include ensuring accurate and timely resolution, review and approval of manufacturing and laboratory investigations, CAPA and identifying any trends.

Shift: Mon - Fri, 9:00AM - 5:00PM

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

• Must have advanced knowledge on the review of deviation investigation and CAPA.
• Must have advanced knowledge on how to perform Root Cause Investigation.
• Must have advanced knowledge and experience with cGMP manufacturing, Quality, and Compliance.
• Must partner with Investigation team for efficiently and timely completion of deviations.
• Proactively seeks to resolve deviations/investigation roadblocks impeding deviation and/or CAPA record on-time closure and release to patients.
• Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Must be able to effectively prepare communications to management with clarity and a high level of accuracy.
• Must be action-oriented and customer-focused, building relationships, problem solving, planning and organizing, conflict management, coaching other and analytical thinking.
• Must possess an independent mindset and tenacity.
• Requires moderate direction to complete complex tasks; completes routine tasks with little or no supervision. Work is self-directed.
• Confident in making decisions for minor issues.
• Is recognized as Subject Matter Expert that facilitates coaching of new hires.
• Contributes to goals within the work group.
• Knowledge of aseptic manufacturing processes.
• Works within cross functional teams to resolve deviations/investigation roadblocks impeding deviation and/or CAPA record on-time closure and release to patients.
• Excellent verbal and written communication skills.

Education and Experience:

• Bachelor of Science in Physical Sciences, Engineering, related discipline, or equivalent is required.
• Minimum of 5 years’ experience in related cGMP environment: Cell Therapy, Pharmaceutical, Biologics, Medical Device operations, with at least 4 years in QA/QC and 1-2 years investigation experience.
• Knowledge of Cell Therapy (CT) operations (manufacturing, QC, packaging/shipping) is preferred.
• Equivalent education, experience or demonstrated competency will be considered.

DUTIES AND RESPONSIBILITIES:

• Supports all activities for the Quality Operations Investigations group.
• Review and approve Site operational investigation, Complaint and Trend Investigations.
• Review and approve Supplemental actions. • Review and approve Impact assessments or Product Quality Evaluation Approval.
• Review and Approve Corrective and Preventive Actions (CAPA Plan, Action approval, Effectiveness Check (EC) Plan, EC execution Approval).
• Participates in Audit and inspection including inspection readiness activities.
• Attend and participate at Investigation and CAPA Review Board (IRB/CRB).
• Review and approve Investigation Protocol/Plan and Summary report.
• Review and approve interim controls (Mitigation protocols) for continued production.
• Review and approve Proactive Initiatives. • Review and approve Standalone actions.
• Contribute to deviation management procedure improvement.