Remote Biologics Investigations Specialist – Cross‑Functional

Amgen; Holly Springs (NC); On-site; USD 107,545 - 145,502; Full time

Benefits offered by this job

Comprehensive employee benefits package

Retirement and savings plan

Flexible work models

Job summary

NCBiotech is looking for a Specialist in Manufacturing Investigations to manage and document deviations at the Amgen facility in Holly Springs, NC. This role involves leading investigations, presenting findings to regulatory inspectors, and driving improvements in procedures.

The successful candidate will have strong cross-functional project management skills and a relevant degree, ensuring compliance within the biotechnology operations. Candidates can expect a competitive salary and comprehensive benefits package.

Responsibilities

• Manage major deviation investigations and document findings.
• Drive process improvements and present to regulatory inspectors.
• Lead cross-functional teams through investigations.

Skills

Cross-functional project management

Communication skills

Problem-solving

Technical writing

Inductive and deductive reasoning

Education

Doctorate degree in relevant field

Master's in chemistry, biology, or engineering & 3 years of experience

Bachelor's degree & 5 years of experience

Associate's degree & 10 years of experience

High school diploma / GED & 12 years of experience

Tools

Veeva QMS

5-whys analysis

Fishbone diagram

Kepner-Tregoe Problem Analysis

Job description

NCBiotech is looking for a Specialist in Manufacturing Investigations to manage and document deviations at the Amgen facility in Holly Springs, NC. This role involves leading investigations, presenting findings to regulatory inspectors, and driving improvements in procedures.

The successful candidate will have strong cross-functional project management skills and a relevant degree, ensuring compliance within the biotechnology operations. Candidates can expect a competitive salary and comprehensive benefits package.