Deviation Investigator

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

Job Description:

The Specialist II, Investigations Team, 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 bachelors 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:

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

The starting hourly compensation for this assignment is within the range of $49.00- 53.21/ hr on W2 Please note that the final individual compensation and any applicable benefits will be determined by your employer of record (and not the Client). Factors influencing this decision may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location of the job. Compensation details are subject to change.