Manufacturing Deviation Investigator & CAPA Lead

United Pharma; New Jersey; Sur place; USD 95 000 - 130 000; Plein temps

Résumé du poste

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.

Qualifications

• 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).

Responsabilités

• 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.

Connaissances

Deviation investigations

Root cause analysis

CAPA process

Technical writing

Cross-functional collaboration

Regulatory compliance

Data trending

Problem solving

Time management

Multitasking

Formation

Bachelor's degree in science or engineering

Advanced degree preferred

Outils

Electronic quality systems

Description du poste

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.