Investigational Analyst

Kindeva•Maryland Heights, MO

6d•Onsite

About The Position

Kindeva is hiring a motivated Sr. Investigational Analyst for its St. Louis Maryland Heights team. This position performs investigative analysis and testing in the Quality Control Investigational Laboratory and manages protocols and experimental studies. Work includes visual and functional evaluations, measurements, testing, and coordinating and overseeing work performed by others to ensure it is executed properly. The role manages projects involving existing, new, or modified auto-injector platforms, component-related changes, labeling, and packaging, combining project management and engineering expertise. The analyst creates and maintains detailed project timelines, budgets, and design history files, and develops solutions when task durations or costs exceed expectations. The position uses equipment hardware and software support, technical reports, detailed drawings, SOPs, protocols, and verbal and written instructions. Responsibilities also include equipment troubleshooting, analyzing and reporting findings, and developing protocols and experimental studies. Equipment listed includes microscopes, Coordinate Measurement Machines (CMM), Fourier Transform Infrared (FT-IR) equipment, CT scanners, and X-ray equipment. The analyst is expected to understand the mechanical aspects of components and device function and serve as the local subject matter expert for new or modified auto-injector platforms led by this position. The role may also support production-process improvements and evaluate complaint and defect samples. The position requires working with minimal supervision and following good documentation practices.

Requirements

Minimum 1–2 years of experience in a pharmaceutical or medical-device laboratory, with experience in one or more of Quality Control, project management, investigations, analytical equipment use, device design, or product development.
Bachelor’s or Master’s degree.
Laboratory experience, preferably in medical devices.
Ability to collaborate well with a team and use creative thinking when investigating.
Ability to work with minimal supervision and maintain good documentation practices.

Nice To Haves

Experience in development and qualification of medical devices.
Bachelor’s or Master’s degree in a science-related field.
Experience with microscopes, CT scanners, X-ray equipment, CMM, FT-IR equipment, and associated equipment software.
Working knowledge of cGMPs, FDA requirements, and ICH guidelines.
Working knowledge of combination products and associated manufacturing processes.
Knowledge of plastics and injection molding.
Knowledge of equipment validation and Gauge R&R.
Knowledge of data integrity.
Knowledge of inspection processes.
Strong user of MS Excel and Microsoft Project.
Visio and Minitab experience.
Six Sigma training.
Well-organized, with good documentation practices.
Good leadership skills and ability to work well with team members.

Responsibilities

Perform testing in the Quality Development Support Laboratory and coordinate and oversee additional testing as needed.
Maintain an up-to-date list of project requests, including priority, status, and due date.
Create initial test documentation, including background information, test procedures, components, equipment, and data sheets.
Analyze findings, summarize analyses, and write technical reports.
Issue NTM and PR and perform root cause analysis as needed.
Perform FT-IR spectra, CT scans, X-ray analysis, and component-specific CMM measurements; operate associated software, create new routines, edit existing programs, and troubleshoot software.
Develop and maintain detailed MS Project timelines and project budgets, keeping them current and addressing variances in task durations or costs.
Provide additional report formats or project plans as requested.
Provide scientific expertise on the device and component aspects of projects and serve as the local subject matter expert for new or modified auto-injector platforms led by this position.
Establish project goals and objectives with the team and hold regular meetings to communicate expectations.
Keep project and team members on target to meet goals and timelines, using MS Project filtering features as needed.
Assist team members and other departments in meeting established goals, timelines, and budgets.
Coordinate, execute, and summarize test trials.
Develop, execute, and summarize experimental protocols.
Trend and report data as needed.
May assist with developing and implementing production-process improvements.
Evaluate complaint and defect samples.
Perform other duties as assigned.