Science and Compliance Specialist

Responsibilities

• Lead and execute investigations for deviations using structured problem-solving methods
• Determine Define/Measure/Analyze elements of investigations using specialized tools
• Investigate root causes and document results in compliance with cGMP standards
• Collaborate with Action Owners to create and verify effective CAPA plans
• Manage multiple investigations simultaneously to ensure timely compliance
• Represent operations during audits and inspections by explaining findings and data
• Analyze operational data to identify trends and opportunities for process improvement
• Partner with Process Engineers to enhance safety, quality, and efficiency
• Serve as an operations SME for aseptic practices and equipment operation
• Draft, revise, and approve SOPs and other controlled documents

Requirements

• BS degree in a science or technical area or equivalent aseptic manufacturing experience
• 2+ years of technical writing experience, preferably in pharmaceuticals
• Knowledge of GMPs and worldwide regulatory agency guidelines
• Understanding of CAPA procedures, specifications, and standards
• Intermediate proficiency in Microsoft Office Suite
• Knowledge of FDA regulations and Good Manufacturing Practices
• Ability to utilize enterprise software systems such as Veeva
• Ability to gown in C/D gowning areas
• Willingness to work overtime, including nights and weekends occasionally

About the Company

Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization (CDMO) that partners with pharmaceutical and biotech companies to bring sterile injectable products to market.