Aseptic Manufacturing Specialist, cGMP & Process Improvement

Alcami Corporation; Morrisville (NC); On-site; USD 80,000 - 100,000; Full time

Job summary

Alcami Corporation in Morrisville, NC, seeks a Manufacturing Specialist - Aseptic to support cGMP sterile manufacturing, troubleshoot events, and participate in continued process verification. You will collaborate with Formulation Development, Manufacturing, QA, Regulatory, EHS and Engineering to ensure robust production of sterile drug products.

Leadership and training abilities are essential. This on-site role emphasizes data analysis, batch-record reviews, deviations, and ensuring compliance

Qualifications

• Requires related bachelor's degree preferred with 2+ years experience in sterile injectable manufacture in a regulated environment.
• Or candidates with high school or equivalent with 8+ years of related experience in sterile injectable manufacture in a regulated environment.

Responsibilities

• Perform data analysis and trend manufacturing processes to identify improvements.
• Review and approve batch records; author changes as needed.
• Train staff on SOPs, batch records, and GMP rationale.
• Provide on-the-floor technical support for commercial and clinical processes.
• Support investigations and CAPAs; close investigations on time.

Skills

Leadership

Data analysis

cGMP knowledge

Technical writing

Training

Education

Bachelor's degree preferred

High school diploma + 8+ years experience

Tools

MS Office

Document control systems

Job description

Alcami Corporation in Morrisville, NC, seeks a Manufacturing Specialist - Aseptic to support cGMP sterile manufacturing, troubleshoot events, and participate in continued process verification. You will collaborate with Formulation Development, Manufacturing, QA, Regulatory, EHS and Engineering to ensure robust production of sterile drug products.

Leadership and training abilities are essential. This on-site role emphasizes data analysis, batch-record reviews, deviations, and ensuring compliance