Senior Investigational Analyst

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

This position will be responsible for performing investigational analysis and testing activities in the Quality Development Support Laboratory along with managing protocols and experimental studies. This includes performing visual and functional evaluations, measurements, and testing as well as coordinating and overseeing testing performed by others and making sure it is executed properly.

Role Responsibilities

• Perform testing in the Quality Development Support Laboratory, coordinating and overseeing additional testing with others as necessary. Keep an up-to-date list of all investigational requests with their priority, status, and due date.

• Create initial test documentation to include items such as background information, test procedures, components, equipment, and data sheets. Analyze findings, summarize analysis, and writing technical reports.
• Issuance of NTM, PR and perform root cause analysis as needed.
• Able to performs the FT-IR spectra, CT-Scans, X-ray analysis and component specific CMM measurements in addition to operate their respective software, including creation of new routines, editing existing programs and software troubleshooting.

• Develops and maintains detailed MS Project timeline and project budget. Keeps these up to date throughout the duration of the project and drives solutions to overcome variances when task durations or costs are exceeded. Provides additional report formats or game plans as requested.
• Provides scientific expertise from the device and component side of the project. Expected to fully understand the mechanical aspects of the components and device function and serve as the local SME (Subject Matter Expert) for new or modified auto-injector platforms being led by this position.
• Establishes and guides team in creating goals and main objectives.
• Holds regular team meetings to communicate effectively what is expected. Ensures that project and team members stay on target to meet established goals and timeline, utilizing filtering features in MS Project to aid in this activity.
• Assists team members and other departments as necessary or where appropriate to meet established goals, timeline, and budget.
• Coordinates, executes, and summarizes test trials. Develops, executes, and summarizes experimental protocols. Trending and reporting of the data as needed.
• May assist with developing and implementing improvements to production processes along with performing evaluations of complaint and defect samples.

Basic Qualifications

• Minimum 5 years in a pharmaceutical/ medical device laboratory with experience in project management, engineering, design or product development.

• Bachelor's or Master's degree in Science or Engineering. Related experience in a technical environment or equivalent combination of education and experience will be considered.
• Laboratory experience, preferably pharmaceutical
• Experience with CT Scanner, X-ray, Coordinate Measurement Machine (CMM), FT-IR equipment and software usage
• Proficient at MS Project and possess excellent leadership ability.

Preferred Qualifications

• Experience in development and qualification of pharmaceutical devices
• Possesses good working knowledge of cGMPs, FDA, and ICH guidelines
• Possesses good 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 preferred.
• Six Sigma training would be beneficial

California residents should review our Notice for California Employees and Applicants before applying.

Equal Opportunity Employer:

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Do you see yourself as part of the Kindeva mission? Click Apply Now Today!

Other details

• Job Family D - Quality - Investigational Quality Control
• Job Function D - Quality
• Pay Type Salary

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