Quality Specialist (GMP/GLP)

Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace.
We are proud to offer a long-term temporary opportunity to work as a Quality Specialist in a prestigious Fortune 500 company located in Pleasant Prairie, WI.
By working with Kelly in this role, you would be eligible for:
- A competitive hourly pay rate with weekly checks - Access to newly expanded Medical Plan options - Online continuing education via the Kelly Learning Center - Several employee discounts - And more! This is a 17 month temporary position at 40 hours per week.
Important information:
This position is recruited for by a remote Kelly office, not your local Kelly branch.
To be considered for this position, please submit your resume.
If you have questions about the position, you may contact the recruiter recruiting for this position email removed however your resume must be received via this job website.
The primary function of this position is to provide Quality oversight to Global Stability Operations programs, including support of International Regulatory Affairs product registrations in Zone III/IV countries, Annual Lot testing of Marketed Products and change controls for SampleManager data management program.
The person in this role is expected to make decisions based on published FDA and ICH Guidance documents, and assist in assuring that Hospira Quality policies and procedures adhere to the current guidelines.
Program management of the transfer of stability administration from satellite locations to Global Stability Operations (GSO).
The transition of satellite locations will include training, transfer of stability designs, test methods, specifications and protocols as well as the creation, approval and execution of transfer project plans.
This may require meeting with international sites off hours to accommodate the different time zones.
Initiation, review and approval of change controls of corporate policies, procedures and local SOPs.
Maintain departmental documents.
Initiation of exception reports and follow-up of assigned activities and CAPAs.
Maintain metrics for the administration group.
Will review and approve annual stability reports.
Minimum - 2 years; Preferred - 5 years The position requires an understanding of project management tools, and an ability to work independently.
Knowledge and experience with GMP, CFR, ICH and related regulations that impact data reporting is critical to performing the duties of the role.
Key leadership skills include fostering teamwork within the Global Stability Operations department for timely collection and reporting of stability data.
Interpersonal skills necessary to accomplish assigned goals and duties include the ability to build relationships within a variety of cross-functional areas, leveraging networks for gathering of world-wide regulatory strategies, and managing conflicts to achieve timely resolution.
If you are interested in this opportunity, please submit your resume now! Local candidates only please Why Kelly ?At Kelly Services , we work with the best.
Our clients include 97 of the Fortune 100 (TM) companies, and more than 70,000 hiring managers rely on Kelly annually to access the best talent to drive their business forward.
If you only make one career connection today, connect with Kelly.
About Kelly Services Kelly Services, Inc.
KELYA, KELYB) is a global leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the world, Kelly provided employment to more than 555,000 employees in 2014.
Revenue in 2014 was $5.
6 billion.
Visit kellyservices.
com and connect with us on Facebook , LinkedIn and Twitter .
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