Scientist :IVD ; root-cause, technical writing, GMP

3 weeks ago

Tucson, United States Maxis Clinical Sciences Full time
Job DescriptionJob Description

100% onsite Position
GMP is required to have
Documentation/writing /technical writing / writing SOP’s is required
Manufacturing experience is required 
Good to have IVD/diagnostic experience
Quality control or research or regulatory experience is good have
Project management experience is good to have but not required
Experience: Minimum of 3 years is required with bachelors but will prefer someone with Masters and PHD
Interview: 1 panel interview  for 60 minutes
Monday to Friday – 8AM to 5PM

Role: Scientist
Location: Tucson (Oro Valley) Onsite only
Shift: 1st Shift, Mon - Fri

PLEASE READ BELOW:
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.

Key skills:
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.

Reagent Operations Scientist – Contractor
Responsibilities: 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.

Production:
¿ 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.

Compliance, Quality & Safety:
¿ Accurately documents investigations and other Quality Records to maintain compliance and Roche's "Right to operate”.
¿ Provide manufacturing product and process information to support global regulatory compliance standards and maintain employee safety. Continuous Improvement
¿ Leverages investigational data to identify and suggest product/process/safety improvement opportunities and/or cost savings by contributing to implementing solutions.

Teamwork and Collaboration:

  • 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.

Education/Experience:
¿ BS with 5 years of relevant experience in production, manufacturing, supply chain or related field is required.
¿ PhD in Science or MS is preferred with 2+ years' experience.

Knowledge Skills and Abilities:
¿ 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.
 

Company DescriptionMaxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.

Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.Company DescriptionMaxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.\r
\r
Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.

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