QA Specialist, Deviation Reviewer and Approver (Sun -Thu)
Bristol-Myers Squibb Company
Summit West, NJ
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: Sunday to Thursday (12:00PM - 8:00PM)
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- Must have knowledge on the review of deviation investigation and CAPA.
- Must have knowledge on how to perform Root Cause Investigation.
- Must have 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.
- Requires minimum direction to complete tasks; completes routine tasks as assigned.
- Confident in making decisions for minor issues.
- Contributes to goals within the work group.
- Basic 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 3 years’ experience in related cGMP environment: Cell Therapy, Pharmaceutical, Biologics, Medical Device operations, with at least 2 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.
- 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).
- Participate 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.
- Ensure appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations.
- Must be skilled in planning and organizing, decision-making, and building relationships.
- Able to effectively work in a dynamic / fast-paced environment.
- Meets and exceeds all safety expectations and adheres to all BMS behaviors and values
WORKING CONDITIONS (US Only):
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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