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Project and Process Excellence Quality Engineer
Tampa, FL, US
Scientific
Bachelors Degree
Full Time, Temporary
Experienced (Non-Manager)
On-site
Medical Devices and Supplies
First Shift (Day)
Tampa, FL, US
Experienced (Non-Manager)
Full Time, Temporary
Medical Devices and Supplies
On-site
Scientific
Bachelors Degree
First Shift (Day)
Job details
Project and Process Excellence Quality Engineer II
Kelly® Science & Clinical is seeking a Project and Process Excellence Quality Engineer II for our client in Tampa, Florida. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
This client is a company focused on/known for/that’s leading the way in pharma/med device. In this role, Person will be responsible for managing the shelf-life and accelerated stability program, including writing accurate and error free study protocols, compiling and interpreting data and summarizing data in stability reports (Annual Product Review etc).
Schedule: On-site Monday through Friday 8am to 5pm
Length of assignment: through 2025 likely to extend.
Pay: $31-33 an hour Depending on experience
Responsibilities
- Processing of incoming test samples into the stability database (data entry/ review/ verification/approval).
- Coordinate and perform functions related to and including: creation of stability studies and stability batch records, ensuring/verifying placement of lots on stability and updating stability database, tracking of stability lots.
- Data entry, trending, analysis, and writing of technical and stability reports supporting annual product review, regulatory filing for new/modified process and/or product investigations.
- Reviews and evaluates stability data. Identifies, analyses, reports and confirms out of trend or out of specifications results to the Department Supervisor / QC lab (chemistry and or micro).
- Collects and analyzes pharmaceutical drug product stability data via appropriate statistical methods.
- Evaluate product degradation trends and confidence limits on annual bases and prepare stability Annual Product Review reports per the established schedule for internal and external customers.
- Prepares written documentation, including protocols and reports, to support product shelf-life claims. Prepare charts, graphs, or forms to go along with the reports.
- Identifies improvements for current procedures and practices and revises documentation accordingly.
- Supports and/or conduct NC investigations.
- Maintenance of quality systems and cGMP compliance for the business by ensuring compliance with processes, procedures and instructions for all activities. .
Requirements
- Bachelor’s degree required.
- 5+ years in Pharmaceuticals or related industry.
- Expertise in statistical principles, methods, and procedures and the ability to instruct others in these areas.
- Knowledge of statistical sampling practices.
- Previous experience in application of statistical models to predict product long term stability.
- Use of Statistical programming, Statistical Modeling, and Statistical Tools (i.e. ScienTek, MiniTab, and Excel) is required. Experience in Microsoft programs, inventory management systems, document control systems, and lab data systems are preferred.
What happens next
Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry—even if this position doesn’t work out, you’re still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.
Helping you discover what’s next in your career is what we’re all about,
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Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.