Job Description

Major Duties And Responsibilities Conduct and manage the resolution of deviations, root cause investigations, impact assessments, and CAPAs. Liaise with multiple groups and organizations to ensure effective collaboration. Proactively manage the progression of investigations and CAPAs to achieve timely closure. Lead and participate in cross‐functional investigation teams. Present investigation findings to key stakeholders and site management. Apply Quality Risk Management and Operational Excellence principles to enable risk‐based decision‐making, drive continuous improvement, and eliminate waste. Investigate Quality Control deviations, including Out‐of‐Specification (OOS) and Out‐of‐Trend (OOT) results. Knowledge And Skills Required Bachelor's degree in chemical/biochemical engineering, biological sciences, or a related discipline with 2?4 years of relevant experience (or equivalent). Prior experience leading cGMP investigations using formal Root Cause Analysis tools required. Strong project management skills, including organization, collaboration, multi‐tasking, and communication. Attention to detail and ability to perform well in a team‐based environment. Excellent verbal and written communication skills, with the ability to present information clearly and concisely. Strong interpersonal and collaboration skills to influence all levels of the organization. Familiarity with SOPs, cGMPs, and working within a regulatory environment preferred. Knowledge of cell culture, recovery, and/or purification biopharmaceutical manufacturing preferred. Contacts Work collaboratively with all departments and across all organizational levels. Working Conditions Assignments primarily occur in the Large‐Scale Cell Culture building, Single‐Use Facility, and Quality Control Laboratory areas, requiring strict adherence to Personal Protective Equipment (PPE) standards. Site is located in Devens, Massachusetts. Decision‐Making Take action, make recommendations, and work with minimal supervision while collaborating with management to resolve challenges. Supervision Received Assignments generally follow defined processes but may require judgment and independent detail definition. Supervisory guidance is provided as needed, with oversight determined by the complexity and impact of the task. 50% Onsite Required 50% onsite required Work Schedule Mon‐ Fri (normal business hours) 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 ($50- $53.22/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. Site is located in Devens, Massachusetts. 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. 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, 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. #J-18808-Ljbffr

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