Telecommute – North Chicago, IL
Title:Quality Contract Writer
Location:North Chicago IL USA
Kelly Serviceshas been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a contract temporary opportunity to work as aQuality Contract Writerat a prestigious Fortune 500? company.This is a REMOTE job.
Length of Contract: 12/31/20
Work schedule: Normal work hours Mon-Fri, or flexible.
Qualification/Experience: BA/BS 8 + years
1. Familiar with clinical supply chain
2. Familiar with GMP
3. Have good written communication skills
4. Demonstrated negotiation skills
Nice to have:Quality agreements writer in pharma industry
Primarily responsible for developing, negotiating, and writing new and revised quality agreements and supporting agreements for R&D.
Interpret, explain and apply the applicable current regulations, guidelines, policies, and procedures
AbbVie R&D Quality Agreement liaison with Operations including negotiating/writing R&D elements for shared R&D / Operations Quality Agreements and associated documents
Manage Quality Agreement life cycle; lead the conduct of cross-functional periodic review evaluations of Quality Agreements to ensure that the Agreements remain current; withdraw/terminate Quality Agreements, as applicable
Manage processes for the timely QA writing/review/approval of Quality Agreement related policies, processes, procedures, templates, and other documentation
Collect, analyze and report metrics pertaining to GxP Compliance
Support audit activities with respect to Quality Agreements and other Quality System elements including audit preparation, responding to audit requests, subject matter expert resource
Effectively communicate audit results, both orally and in writing. Review corrective action plans/audit responses for adequacy and approve if adequate
Review/edit GxP Service Provider business contracts/agreements and related documents for a Quality related subject matter to ensure compliance with current regulations/guidance/industry standards and AbbVie Quality System requirements.
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.
AtKelly, 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.
North Chicago, IL