Deviation Investigator

About the role

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.

Responsibilities

• 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

Qualifications

• 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)

Skills

• 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

Pay

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.

Schedule

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