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.
- 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).
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.
- 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.
Reporting Relationship
- This position reports to a QA Operations Manager.
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)
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.
About ASK Consulting
ASK Consulting is an award-winning, woman-owned staffing and recruitment solutions provider with over three decades of industry experience. We specialize in connecting businesses of all sizes?across IT, healthcare, engineering, finance, and more?with top-tier professionals. Backed by a global network and personalized service approach, our team is dedicated to building meaningful partnerships that drive organizational success and empower job seekers to excel in their careers.
Benefits
ASK Consulting provides comprehensive, ACA-compliant health coverage, along with dental, vision, Short- and Long-Term disability for eligible employees. We also offer commuter benefits, a 401(k) plan with no matching, and a referral bonus program. In addition, ASK Consulting offers unpaid leave and paid sick leave as required by law.
Equal Opportunity Employer
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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Fair Chance Employment Notice
If you are selected for a position at, ASK Consulting, your offer is contingent upon successfully meeting several requirements, which may include a criminal background check. In accordance with all applicable federal, state, and local ?Fair Chance? ordinances and laws?such as the Los Angeles County Fair Chance Ordinance (FCO) and the California Fair Chance Act (FCA)?we consider qualified applicants with arrest or conviction records. The background check will evaluate whether any criminal history could reasonably pose a direct, negative impact on job-related safety, security, trust, regulatory compliance, or overall suitability for the role. Findings that raise concerns may result in withdrawal of a conditional job offer.
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This posting does not constitute an offer of employment. All applicants seeking positions in the United States must be legally authorized to work in the United States. Submitting intentionally false or fraudulent information in response to this posting may disqualify you from consideration. Any eventual offer of employment will be considered ?at will,? regardless of the expected assignment duration.
