Deviation Investigator

United Pharma; New Jersey; Vor Ort; USD 95.000 - 130.000; Vollzeit

Zusammenfassung

United Pharma, Warren, NJ, seeks a Specialist II in the Investigations Team to lead deviation investigations and perform root cause analyses within Manufacturing Operations.

You will collaborate across functions to propose CAPAs, develop CAPA plans, and ensure effectiveness while meeting timelines and regulatory requirements. A strong emphasis on data trending, problem solving, and professional technical writing is essential.

Qualifikationen

• Requires a bachelor’s degree in science or engineering.
• Minimum 5 years of relevant work experience.
• Experience in a biopharmaceutical manufacturing facility and aseptic environment preferred (CAR T a plus).

Aufgaben

• Lead deviation investigations using root cause analysis tools.
• Summarize progress to site departments and stakeholders.
• Develop CAPA plans and assure CAPA effectiveness with cross-functional teams.
• Ensure investigations are completed within system timelines and communicate delays/risks.
• Initiate change control documentation when needed.

Kenntnisse

Deviation investigations

Root cause analysis

CAPA process

Technical writing

Cross-functional collaboration

Regulatory compliance

Data trending

Problem solving

Time management

Multitasking

Ausbildung

Bachelor's degree in science or engineering

Advanced degree preferred

Tools

Electronic quality systems

Jobbeschreibung

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)