Manufacturing Investigations Specialist CAPA & Compliance

FUJIFILM Biotechnologies; North Carolina; Sur place; USD 85 000 - 110 000; Plein temps

Avantages offerts par ce poste

Medical, dental, vision coverage

401(k) savings plan

Paid vacation and holidays

Résumé du poste

FUJIFILM Biotechnologies in North Carolina is seeking an Investigator 2, Manufacturing to conduct investigations across Cell Culture, Fermentation and Downstream programs, identifying CAPAs and ensuring timely closure within required timeframes.

You will organize cross-functional teams, analyze performance metrics, and support quality improvement initiatives while presenting findings to regulatory agencies and stakeholders.

Qualifications

• High School Diploma or Equivalent with 9 years of industry experience OR
• Associate's degree with 7 years of industry experience OR
• Bachelor's degree with 5 years of industry experience OR
• Master's degree 3 years of industry experience

Responsabilités

• Work on event, minor and major investigations with site and global SOPs.
• Identify and address CAPAs based on root cause analysis and ensure effectiveness.
• Organize and lead cross-functional investigational teams including internal and external members.
• Track and analyze performance metrics to identify trends and drive improvements.
• Participate in Problem Analysis sessions and support documentation revisions.

Connaissances

CAPA implementation

Cross-functional leadership

cGDPs/cGMPs

Data analysis

Technical writing

Formation

Bachelor's degree in science

Master's degree in related field

Outils

Excel

PowerPoint

Word

Description du poste

FUJIFILM Biotechnologies in North Carolina is seeking an Investigator 2, Manufacturing to conduct investigations across Cell Culture, Fermentation and Downstream programs, identifying CAPAs and ensuring timely closure within required timeframes.

You will organize cross-functional teams, analyze performance metrics, and support quality improvement initiatives while presenting findings to regulatory agencies and stakeholders.