Senior Specialist, Quality Assurance

The Senior 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.

• Collaborates cross-functionally on deviations to ensure accurate root because 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 (SME) in cGMP, GDocP, Data Integrity (DI)/ALCOA principles, risk management and right first time (RFT).

• 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 technical writing of 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.
• Mentor and onboard 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.
• Support COMPASS Philosophy by 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 and Kaizen events.
• Participate as a champion for site-wide initiatives aimed at strengthening Quality Culture and improving processes, such as DI, Change Controls, and Compliance programs.

• This position reports to a QA Operations Manager.

• Bachelor?s degree in STEM (Science, Technology, Engineering and Math education) and/or equivalent combination of work experience is required.
• Experience:
• 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.

Minimum 50% onsite (Tuesday preferred).

M-F;
Standard Hours (8am-5pm).

The starting hourly compensation for this assignment is $68-72.76/hr final compensation will be determined by the employer of record ASK Staffing, Inc.

ASK Consulting is an equal opportunity employer and does not discriminate against employees or applicants based on race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability, veteran status, or any other classification protected by federal, state, or local laws.

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