GMP Compliance Lead — Audit Readiness & CAPA Champion

Fresenius Kabi; Grand Island (NE); On-site; USD 74,000 - 104,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Life insurance

Disability coverage

401(k) with company contribution

Wellness program

Job summary

Fresenius Kabi in Grand Island, NE is seeking a Compliance Officer to manage quality systems from a FDA and global perspective. You will lead audits, investigate deviations, manage CAPA and regulatory documentation to ensure audit readiness.

The role requires 3–5 years of pharma experience, strong GMP knowledge, and attention to detail. Salary includes a 6% annual target bonus and comprehensive benefits.

Qualifications

• BA/BS degree in science field or equivalent.
• 3–5 years of pharma or related experience with emphasis on cGMP.
• Solid knowledge of GMP, EU, GLP and FDA trends/guidelines.
• Strong problem-solving and trouble-shooting abilities.
• High attention to detail in documentation and records.

Responsibilities

• Serve as compliance SME for internal audits and support external/regulatory audits.
• Coordinate information for Regulatory Requests and ensure commitments are met.
• Conduct deviation investigations and root-cause analysis with CA/PA determinations.
• Lead internal audit teams to address noncompliance in the plant.
• Maintain Site Master File and contribute to Annual Product Quality Reviews.
• Ensure deadlines are met and extensions properly justified.
• Maintain site information in global databases.

Skills

Problem solving

Attention to detail

Interpersonal communication

Regulatory liaison

Education

BA/BS Degree in science field

Tools

MS Office

Job description

Fresenius Kabi in Grand Island, NE is seeking a Compliance Officer to manage quality systems from a FDA and global perspective. You will lead audits, investigate deviations, manage CAPA and regulatory documentation to ensure audit readiness.

The role requires 3–5 years of pharma experience, strong GMP knowledge, and attention to detail. Salary includes a 6% annual target bonus and comprehensive benefits.