Deviation Investigator

Bristol Myers Squibb; New Jersey; On-site; USD 68,880 - 73,302; Full time

Job summary

A leading biopharmaceutical company in Warren, NJ, is seeking a Specialist II for their Investigations Team. In this role, you will lead thorough investigations in manufacturing operations, focusing on deviation investigations, root cause analyses, and CAPA processes. Candidates should possess a relevant degree and 5+ years of experience, preferably in a regulated environment. This position requires strong technical writing and problem-solving skills. This is a contract position with on-site work requirements, offering an hourly compensation of $50-$53.21.

Qualifications

• Experience in deviation investigations using root cause analysis tools.
• Experience with the CAPA process and ability to verify effectiveness.
• Technical writing skills and effective collaboration in cross-functional teams.

Responsibilities

• Conduct thorough investigations with root cause analysis tools.
• Summarize findings to relevant site departments.
• Work with teams to propose effective CAPAs and assure effectiveness.

Skills

Deviation investigations

Root cause analysis

Technical writing

Problem-solving techniques

Cross-functional collaboration

Education

Bachelor's degree in science or engineering

5 years of relevant work experience

Job description

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.

Duties And Responsibilities

• 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

Required Competencies (Knowledge, Skills, Abilities)

• 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

Global Regulatory And CGMP Requirements

• 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

Education And Experience

• 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)

Working Conditions (Warren, NJ Site)

• 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 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.

Applicants with disabilities may request this notice in an alternative format by contacting [e-mail].

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.