On-Site Aseptic Manufacturing Specialist - Lead & Train GMP

Alcami Corporation; Morrisville (NC); Presencial; USD 70.000 - 90.000; Jornada completa

Descripción de la vacante

Alcami Corporation is seeking a Manufacturing Specialist - Aseptic to support cGMP manufacturing and troubleshoot events, preparing and evaluating continued process verification activities. 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 required. The role emphasizes on-site performance, working with cross-functional teams, and applying GMP concepts to

Formación

• Bachelor’s degree in a related field with 2+ years of sterile injectable manufacturing experience in a regulated environment.
• Or a high school diploma with 8+ years of sterile injectable manufacturing experience in a regulated environment.
• At least 1 year of technical writing experience (deviations, SOPs, batch records).

Responsabilidades

• Perform data analysis and trending of manufacturing processes to identify improvements.
• Measure unit operation durations to optimize scheduling to meet facility and client needs.
• Author change controls to support investigations and process changes.
• Author investigations and help close investigations on time.
• Review and approve batch records and perform batch record reviews.
• Train manufacturing staff on procedures, batch records, and GMP rationale.
• Provide on-the-floor support for commercial, clinical, and validated processes.
• Support clients as a subject matter expert for products.

Conocimientos

Data analysis

Leadership

Training

Problem solving

Microsoft Office

Communication

Educación

Bachelor’s degree

High school diploma

Herramientas

Microsoft Office

Batch records systems

Descripción del empleo

Alcami Corporation is seeking a Manufacturing Specialist - Aseptic to support cGMP manufacturing and troubleshoot events, preparing and evaluating continued process verification activities. 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 required. The role emphasizes on-site performance, working with cross-functional teams, and applying GMP concepts to