Stability Coordinator

Stability Coordinator

Kelly Services has provided outstanding employment opportunities to the most talented professionals in the marketplace. Today, we are proud to offer an excellent contract opportunity for a Stability Coordinator with our client, a leader in the medical device industry, located in Tampa, Florida

This position performs in depth analysis of pharmaceutical products stability data.  The Person will be responsible for managing the shelf life and accelerated stability program, including writing accurate study protocol, compiling and interpreting data and summarizing data into stability reports including Annual Product review.

Work is performed in an office/ laboratory and/or warehouse environment. This position performs in-depth evaluation and analysis of pharmaceutical products stability data. 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).

 

Responsibilities:

Processing the incoming test samples into stability database.

Coordinate and perform functions to creations of stability study, stability batch record, verifying placement of lots on stability, updating database and tracking lots.

Data entry, trending analysis and writing of technical and stability reports to support annual product review, regulatory filings and/ or product investigations.

Reviews and evaluates stability data.  Identifies, analyzes, reports and confirms of trend or out of specification to the appropriate lab manager.

Looks for variations in trends and helps establish control, alert and action limits.

Uses appropriate statistical tools to analyze stability data.  ( ScienTek and MiniTab)

Evaluate product degradation trends and confidence limits on annual bases and prepares stability Annual Product review for internal and external customers.

Identifies improvements for current practices and procedures and revises documents accordingly.  Responsible for the department documentation, crates and closure of CR and QCR.

Support/conduct NC investigation.

REQUIREMENTS

BS Degree in science field

5 plus years of industrial experience in the pharma/med device industry

Knowledge of cGMP

Knowledge of statistical tools ( EXCEL, mintab, ScienTek)

Experience with Microsoft programs, document control systems, and inventory management systems

Knowledge of statistical sampling

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch.  Applicants must be legally permitted to work in the United States.

Why Kelly?

  • As a Kelly Services employee, you will have access to numerous perks, including:
  • Exposure to a variety of career opportunities as a result of our expansive network of client companies 
  • Career guides, information and tools to help you successfully position yourself throughout every stage of your career
  • Access to more than 3,000 online training courses through our Kelly Learning Center
  • Weekly pay and service bonus plans
  • Group-rate insurance options available immediately upon hire*

Why Kelly®?

As a worker today, it’s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what’s next is what we’re all about. We know what’s going on in the evolving world of work—just ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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