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Operation Support Specialist - Weekend AM at Simtra BioPharma Solutions - ApplyBlast

Operation Support Specialist - Weekend AM

Simtra BioPharma Solutions

3 days ago

3.1 on Glassdoor

Bloomington, Indiana, United States

Onsite

Full Time

Medior

0 applicants

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About this role

The Operations Support Specialist serves as an embedded partner to manufacturing shifts, focusing on deviation event response, investigation authoring, and driving continuous improvement actions. This role ensures safe and compliant operational returns after incidents while maintaining high standards of quality and regulatory compliance. The position requires close collaboration with manufacturing, quality, and technical teams to capture critical event details and execute corrective actions.

Responsibilities

Author and close manufacturing deviations with root cause analysis
Drive assigned CAPAs and continuous improvement actions
Support deviation event response and investigation initiation

Skills

Qualifications

Bachelors degree in Life Sciences, Engineering, or related field

About Simtra BioPharma Solutions

simtra.com

Headquarters

Parsippany, New Jersey, United States

Company Size

1001-5000 employees

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Simtra BioPharma Solutions is a contract development and manufacturing organization (CDMO) focused on sterile injectable products. They offer end-to-end services — from formulation and analytical development through aseptic fill/finish, packaging, quality and regulatory support — to advance programs from clinical stages to commercial supply. Simtra emphasizes flexible product delivery options and a compliance-driven approach to meet biopharma partners’ timelines and manufacturing requirements.