Sr. Specialist, Quality Assurance

Bristol Myers Squibb • Bothell, WA

19d

About The Position

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. 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. Position Summary The Sr. Specialist, Quality Assurance is an individual contributor role within the QA Investigations (QAI) team providing quality oversight of Deviation related processes for clinical and commercial Cell Therapy manufacturing at BMS Bothell. This role: Collaborates cross-functionally on deviations to ensure accurate root cause analysis (RCA) and corrective and preventive actions (CAPA) have been identified. Ensures the deviation and associated records contains technical merit and completeness according to regulatory expectations. Coaches customers and team members on the deviation process and navigation within the electronic management system. Acts as a Subject Matter Expert in cGMP, GDocP, Data Integrity (DI)/ALCOA+ principles, risk management and right-first-time (RFT).

Requirements

• Bachelor’s degree in STEM (Science, Technology, Engineering and Math education) and/or equivalent combination of work experience is required.
• 3+ years of cGMP experience in a regulated environment, preferably in a QA or Manufacturing Science and Technology (MSAT) role.
• 2+ years working within quality systems such as Deviation Management and Document Management.
• Experience in FDA/EMA regulations in the biotechnology, pharmaceutical industry; experience in protein biologics or cellular therapy field is preferred.
• Experience with use of RCA tools and methodologies and executing deviation investigations and CAPA.
• Strong attention to detail with effective organizational, planning, and time management skills.
• Proven track record of making quality decisions based on risk impact to patient, product, and process; escalates complex quality events.
• Strong collaboration and communication skills to influence cross-functional teams and ensure alignment with quality strategy and priorities.

Responsibilities

• Conduct timely and structured reviews of deviations, lab investigations, standalone actions, proactive initiatives and their supporting records using a risk-based approach to ensure thoroughness, technical merit and compliance with regulatory requirements.
• Serve as the QA point-of-contact for deviations related to trend investigations and ineffective effectiveness check investigations, providing guidance and oversight.
• Collaborate with cross-functional investigation teams to align investigation strategies, including containment and mitigation activities, interviews, GEMBA walks, process observations and RCA.
• Support investigation teams in identifying and implementing effective CAPAs, presenting findings at review boards, and driving RFT outcomes.
• Assess and communicate the importance and impact of lot association within deviations, including impact assessments and their relation to product disposition decisions.
• Apply advanced RCA tools appropriately, demonstrating an understanding of when, where, and how to utilize each tool for effective investigations.
• Ensure accurate assignment of deviation classifications in accordance with established procedures.
• Troubleshoot and resolve issues related to deviations, escalating as necessary to ensure timely resolution.
• Influence and drive improved quality and cGMP compliance within investigation teams, with a focus on enhancing compliance and audit readiness.
• Identify and communicate inconsistencies in investigation reviews to promote calibration and alignment across the team.
• Mentor new hires and existing customers by providing training on risk-based quality decision-making, deviation review ownership, human error investigation principles, and technical writing best practices.
• Develop and deliver delta training sessions in response to procedural updates related to deviation management.
• Promote COMPASS Philosophy by actively participating in Tier 2 meetings and initiatives.
• Proactively identify gaps and opportunities within the deviation and action management processes, leading continuous improvement initiatives to enhance efficiency and effectiveness.
• Champion continuous improvement projects, including visual management, QA dashboards, Kaizen events, 5S activities, and cross-functional GEMBA walks.
• Participate as a champion for site-wide initiatives aimed at strengthening Quality Culture and improving processes, such as DI, Change Controls, and Compliance programs.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level