Manufacturing Investigations Specialist CAPA & Compliance

FUJIFILM Biotechnologies; North Carolina; On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) savings plan

Paid vacation and holidays

Job summary

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

Responsibilities

• 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.

Skills

CAPA implementation

Cross-functional leadership

cGDPs/cGMPs

Data analysis

Technical writing

Education

Bachelor's degree in science

Master's degree in related field

Tools

Excel

PowerPoint

Word

Job description

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.