cGMP Manufacturing Operations Specialist & Process Lead

Alcami-5; Michigan; Presencial; USD 85.000 - 120.000; Jornada completa

Descripción de la vacante

Alcami is seeking a Technical Operations Specialist to support cGMP manufacturing and maintain product quality. You will provide technical oversight, troubleshoot production issues, and drive continued process verification across commercial and clinical operations.

You will collaborate with Technical Services, Operations, Quality, Engineering, and EHS to resolve issues, route critical documents, and train team members, ensuring timely reviews and compliant manufacturing.

Formación

• 5+ years of experience in a pharmaceutical cGMP Manufacturing setting.
• 1 year of experience in Technical Writing (deviations, SOPs, Batch Records, etc.).
• Demonstrated leadership and training experience.

Responsabilidades

• Support commercial and clinical cGMP manufacturing operations using data analysis to identify areas of improvement and overall manufacturing trends.
• Troubleshoot unexpected manufacturing events and production issues as a process SME, authoring investigations and facilitating the closure of investigations in a timely fashion.
• Prepare, execute, and evaluate Continued Process Verification (CPV) activities; monitor process performance and identify opportunities for improvement; provide ongoing technical support to manufacturing teams.
• Coordinate activities with cross-functional teams to resolve documentation and manufacturing process issues, CAPAs and deviations; ensure alignment across functions.
• Provide training to manufacturing staff on operating procedures, batch records, and cGMP processes.

Conocimientos

Data analysis

Leadership

Technical writing

Cross-functional collaboration

Educación

Bachelor's degree

Herramientas

Microsoft Office

Descripción del empleo

Alcami is seeking a Technical Operations Specialist to support cGMP manufacturing and maintain product quality. You will provide technical oversight, troubleshoot production issues, and drive continued process verification across commercial and clinical operations.

You will collaborate with Technical Services, Operations, Quality, Engineering, and EHS to resolve issues, route critical documents, and train team members, ensuring timely reviews and compliant manufacturing.