Stability Specialist Job Listing at Kelly Services in Fort Washington, PA (Job ID 9306842)

Description

R&D Stability Scientist
Fort Washington, PA
Full-Time
1st Shift

Kelly Outsourcing & Consulting Group (KellyOCG), a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a R&D Stability Scientist for a long-term engagement at one of our Global clients in Fort Washington PA.

Benefits and Compensation:
Fully benefitted position. As a KellyOCG employee, you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. You'll also be eligible for paid time off, including holiday, vacation, and sick/personal time.

*This position is BYOD (bring your own device). Here are the specifications for the computer: 

Intel i5 or above processor
8GB RAM or higher
WINDOWS 11
Microsoft Windows 365

SUMMARY
This assignment within the R&D Self-Care Stability group will have primary responsibility for documentation and verification of stability protocols, stability reports and other stability documents, in alignment with relevant requirements and using applicable templates.

RESPONSIBILITIES                                 

• Additional responsibilities may include stability assessments, stability committee presentations, proactive tracking of stability study initiation, stability sample management, stability storage and stability testing activities, and management of non-conformances deviations and change controls.
• As needed, statistical analysis of stability data, including assessment of out-of-trend and out-of-specification results and expiry evaluation may be required.
• Strong oral and written communication skills are required to communicate effectively at team meetings, and with internal business partners, including Quality, Regulatory, Analytical, Technical, Raw Materials, Laboratory, Suppliers, and Project Management.
• Must contact internal and external partners for information and supporting documentation. Communicate with internal and external document approvers to ensure timely review and approval of stability documents.

QUALIFICATIONS

• Requirements Education: BS or MS, in analytical chemistry or related field
• Background in stability and analytical chemistry, common to the pharmaceutical industry, is highly preferred.
• Experience with stability guidance documents ICH, SUPAC, WHO, Health Canada Post NOC, etc. is preferred.
• Experience with electronic systems for managing documentation, investigations, and associated change control system is preferred.
• Strong background in Word and Excel is required.
• Experience with Documentum based document storage system is preferred.
• Background in routine analytical testing e.g., active pharmaceutical ingredient, drug product and/or raw materials, as well as knowledge and experience with regulatory requirements is preferred.
• Good working knowledge of computer systems is required.

APPLY NOW FOR IMMEDIATE CONSIDERATION!!
#P2

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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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.

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