Reagent Operations Scientist

Software Guidance & Assistance, Inc., (SGA), is searching for a Reagent Operations Scientist for a contract assignment with one of our premier Pharmaceutical services clients in Tucson, AZ.

Responsibilities :

Candidates will support Global Operations Daily Support. This role will support day-to-day operations in Reagent manufacturing, including troubleshooting and root-cause analysis, non-conformance documentation, process improvements, temporary deviations, supplier change notifications, and design change.

• Communication and organizational skills, and the ability to identify opportunities that would drive the business forward while complying with quality processes and objectives.
• Utilize a wide variety of scientific techniques to determine root cause, while remaining compliant with the Quality System and Global Regulatory Standards.
• Responsible for issue identification, scoping and troubleshooting of production related issues with driving to issue resolution.
• Responsible for developing and executing investigational plans, and determining root cause in a collaborative matrix environment.
• Analyzes data, evaluates results, forms conclusions, and develops resolution plans using a wide variety of scientific principles and concepts.
• Provides technical input for impact assessment and design changes.
• Maintains broad knowledge of state-of-the art principles and theories.
• Accurately documents investigations and other Quality Records to maintain compliance and the firm's "Right to operate .
• Provide manufacturing product and process information to support global regulatory compliance standards and maintain employee safety.
• Leverages investigational data to identify and suggest product / process / safety improvement opportunities and / or cost savings by contributing to implementing solutions.
• Proactively collaborates with peers in other shifts / functions.
• Collaborates with support functions to drive value stream, lean manufacturing improvement and global projects / initiatives.
• Other duties as assigned.

Required Skills :

• BS with years of relevant experience in production, manufacturing, supply chain or related field is required.
• Ability to apply investigational techniques and data analysis to the root cause determination.
• Ability to scope the investigation and corrective actions as appropriate for the situation.
• Ability to analyze and present data at an appropriate level of detail applicable to the situation.
• Ability to broadly evaluate how an issue may impact other products / processes.
• Demonstrates system-level thinking and applies broad scientific knowledge to multi-disciplinary projects.
• Applies advanced technical writing skills to produce reports and documents; writes independently; evaluates the writing of others.
• Advanced scientific background (Chemistry / Biochemistry); Experience with IHC / ISH / ICC; root-cause investigation experience;

technical writing / writing for compliance; Good Manufacturing Practices (GMP); comfortable with fast-paced environment and prioritization.

Preferred Skills :

• PhD in Science or MS is preferred with + years' experience.
30+ days ago