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Stability Specialist

Kelly Services

Rochester, NY
Job Code:
  • Government
  • Regulatory Affairs
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Job Details

Job Title Stability Specialist

Jobid US41ALJM_BH1421007

Location: Rochester, NY, 14608, USA

Description **Stability Specialist**

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 Specialis** t with our client, a leader in the medical device industry, located in Rochester, New York.

**Responsibilities** : Review and evaluate stability data and trends ensuring that they continue to meet specifications and support product expiry. Maintain vendor logs for annual stability commitments, protocols and invoices. Define, maintain and improve relationships with external vendors to ensure adequate visibility into stability testing, investigations and reporting. Manage finance activities for stability products such as the creation of purchase orders, receipts, tracking invoices received from vendors and monthly accruals. Assist Regulatory Affairs with annual product reviews by providing stability reports. Continuously evaluate current stability processes and procedures for products that are manufactured externally and recommend improvements to management.

**Job Qualifications** Education Bachelor s degree in Chemistry, or similar scientific field.

Experience Minimum of 1- 2 years of work experience in QC laboratory environment. Understanding of pharmaceutical stability programs and processes is highly preferred. Working knowledge of cGMPs in a FDA regulated environment is required. Knowledge/Skills/Abilities Knowledge of ICH and FDA guidelines regarding stability requirements is a plus. Analytical chemistry knowledge, including HPLC, dissolution and wet chemistry techniques preferred. Ability to work with minimal guidance to take a project from start to finish. Ability to handle routine details and unexpected changes without losing focus on own projects. Ability to determine task priority and maintain established deadlines. Requires strong interpersonal and communication written and oral skills and the ability to interact effectively with peers, upper management and external customers. Exceptional organizational skills and attention to detail required. Strong computer skills including word processing, spreadsheet and presentation software required.

**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** **®** **?**

At KellyServices ® , we work with the best. Our clients include 95 of the Fortune100 ™ companies, and more than 70,000 hiring managers rely on Kelly annually to accessthe best talent to drive their business forward. If you only make one career connection today, connectwith Kelly.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 peoplearound the world and have a role in connecting thousands more with work through our global network oftalent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect with us on Facebook, LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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