Deviation Investigator

The Specialist II, Investigations Team, Clinical Site Manufacturing, Science and Technology (MSAT) is responsible for leading investigations in support of Manufacturing Operations at the Warren, NJ site. This position will be assigned deviation investigations, facilitating teamwork to execute all components within applicable timelines. Deviation investigations will include execution of thorough root cause analyses (RCA) as well as identification of corrective and preventative actions (CAPA) across multiple platforms / programs.

• Under the direction of the Senior Manager, investigations Team, perform the following:
• Conduct thorough investigations utilizing root cause analysis tools focusing on manufacturing investigations
• Summarize progress to site departments
• Work with functional teams to propose effective CAPAs, develop CAPA plans and assure CAPA effectiveness
• Ensure all investigations are completed within system timelines
• Notify any delays / risks upon discovery
• Manage issues and solve problems with medium guidance
• Initiate change control documentation if needed
• Continuously living the Patients First mission and fostering a Right First Time mindset

• Experience of deviation investigations utilizing root cause analysis tools
• Experience in the CAPA process and ability to identify and verify effectiveness
• Technical writing skills and ability to collaborate effectively in cross functional teams
• Proven ability to understand, follow, interpret, and apply accurately and completely

• Knowledge of data trending and tracking
• Problem-solving techniques, technical adeptness, and critical thinking
• Ability to set priorities, manage timelines and effectively update priorities as needed
• Ability to work with management to support corporate and departmental goals
• Ability to utilize electronic quality systems
• Time management, organizational, and multi-tasking abilities

• Requires a bachelor's degree in science or engineering (advanced degree preferred)
• Minimum 5 years of relevant work experience, preferably in a health authority regulated environment
• Previous experiences working in a biopharmaceutical manufacturing facility and an aseptic environment is preferred (CAR T a plus)

• Physical / Mental Demands
• Work is performed in a typical office environment, with standard office equipment that is available and able to be utilized
• Work is performed seated but may require standing and walking for approximately 25% of the time
• Environmental Conditions
• Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of the position. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.

There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

100% onsite

Work Schedule:

Mon-Fri- 8:30 am
-5 pm (need to be flexible to work last hours as needed occasionally)

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 - $53.21/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.

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 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…