Senior Specialist, Quality Assurance

About the role

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. This Role Collaborates cross-functionally on deviations to ensure accurate root because analysis (RCA) and corrective and preventive actions (CAPA) have been identified.

Responsibilities

• Duties/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 technical writing of RCA.
  • Support investigation teams in identifying and implementing effective CAPAs, presenting findings at review boards, and driving RFT outcomes.
  • Affirm accuracy 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.
  • 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.

Qualifications

• Education: 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.

Onsite/Hybrid

Min. 50% Onsite (Tuesday Preferred)

Work Schedule

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

Pay

This posting is for a contract assignment with ASK Staffing DBA ASK Consulting to provide services to Bristol Myer-Squibb. The starting hourly compensation for this assignment is the following range ($68- $72.76/hr).

While the final, individual compensation and any available benefits will be determined by your employer of record ASK Staffing, Inc (and not BMS), factors that will be included in making the final determination may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location where the job is performed.

The starting hourly compensation may be subject to change.