Complaint QA Scientist: Investigator & CAPA Specialist

TechDigital Group; Miami (FL); Vor Ort; USD 50.000 - 85.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Complaint Handling Quality Assurance Scientist I to enhance quality and regulatory compliance in customer complaint investigations. This role is pivotal in ensuring that complaints are accurately documented, classified, and investigated, particularly within the Chemistry/Immunoassay product line. The successful candidate will engage in data analysis, problem-solving, and documentation within a highly regulated environment. With a focus on collaboration across various functions, this position offers a unique opportunity to contribute significantly to product quality and improvement initiatives. If you are passionate about quality assurance and eager to make a difference, this role is for you.

Qualifikationen

• 2 years' experience in a laboratory or Quality role.
• Good knowledge of FDA QSR and ISO 13485 requirements.

Aufgaben

• Review and record customer complaint investigations.
• Conduct complaint trending reviews for CAPA eligibility.
• Collaborate with various teams for effective complaint handling.

Kenntnisse

Data analysis

Problem-solving

Documentation skills

Communication skills

Ausbildung

Degree in Science or Engineering

Tools

Smart Solve

Jobbeschreibung

What are the top 3 skills required for this role?
SQL, Autosys, Openshift/Kubernetes, Linux, Shell scripting, AI-adoption

Job Description/ Responsibilities
Systems Operations Engineer (App Ops support):
This position is a senior level technical role that will lead application support of production systems with a focus on incident management, problem management, change/release, and other ITIL based functions. The individual will need to lead discussions and collaboration with development and business teams and be able to develop a deep understanding of applications and business functionality. The position will be working in a corporate environment with large, complex, and critical applications across a wide range of technologies. Examples include large, complex, Tier 1 IIS/.NET/SQL applications, web hosting with multiple server tier levels, and application and server level clustering and load balancing. This position will follow corporate policies regarding security, documentation, audit and change control processes. This individual will collaborate with a team of US and India engineers maintaining the availability and performance of the production systems.
Position Responsibilities and Expected Outcomes:
• Drive adoption of core tooling and align to ITIL services
• Execute incident, problem, change and release management across a wide range of applications and technologies
• Drive remediation activities, run incident bridges, and provide status on active issues
• Drive root cause identification and preventative actions
• Effectively multi-task across a wide range of activities
• Communicate effectively (both verbal and written) across multiple teams
• Work with vendors and vendor products to troubleshoot issues
• Identify gaps and single points of failure in current technology process or design
• Create, Update and maintain all aspects application specific troubleshooting documentations and runbooks along with training/knowledge transfer to other team members
• Create, Update and maintain all aspects of application specific build/configuration documentation along with training/knowledge transfer to other team members
• Drive identification and development of automation for repetitive tasks
• Ensure quality, security and compliance requirements are met for supported area
• Execute daily maintenance tasks and proactive review of the production environment
• Work incident, problem, and request ticket queues to ensure all tickets are completed on time and to satisfaction of requester
Will require some off hour support and on-call rotation for system changes and issue investigation and coordination with offshore teams.
It's a large team of application support engineers, covering HR and Legal based application suites. Need to be AI-inclined, right attitude with flexibility of work hours when needed and good comm skills/soft skills.