*** MUST BE ABLE TO WORK ON A W/2 HOURLY BASIS (without Sponsorship) *** NO C2C *** REMOTE/ onsite blend ***
Our Client is expanding and currently seeks a
IT QUALITY COMPLIANCE SPECIALIST
For a 6+ month assignment with possible extensions!!
LOCATION: Bothell, Washington
Leverage your FDA - EMA - VALIDATION skills
to help take your career with our Client to
the "Next Level" for 2021 and beyond!
Our Client is seeking an IT Quality & Compliance Specialist to work cross-functionally to support compliance-related activities for GxP electronic systems and applications. This role is an individual contributor, primarily focused on leading investigations and root cause analyses for deviations, and assisting with tracking of Quality Systems commitments (e.g., CAPA and Change Control actions) supporting site computerized systems. The IT Quality & Compliance Specialist will partner with IT, Quality, PMO, Business Owners, and Technical Owners to drive completion of Quality Systems deliverables for electronic systems and applications throughout their lifecycle to ensure regulatory and procedural compliance, supporting the site's right to operate.
• 5+ years of experience in FDA / EMA regulated industry, biopharmaceuticals or cell therapy manufacturing is preferred
• 3+ years of direct experience with Quality Systems records (Deviations, CAPAs, Change Controls, SOPs) in a cGMP regulated environment
• Experience with the use of root cause analysis techniques and methodologies like Fishbone / Ishakawa, Is / Is Not, Pareto Chart (80/20 Rule), Process Mapping, 5-Whys, Contradiction Matrix, and/or Human Error Analysis
• Experience with the use of Quality Systems records documentation and reporting systems
• Familiar with diverse computerized systems: MES, ERP, LIMS, Validation Lifecycle / Testing Software, QMS, Learning Management System
• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
• Strong computer skills with the Microsoft Office application suite and familiarity with various electronic systems used in manufacturing
• Detail oriented team player with effective planning, organization, and execution skills
• Proven experience working on teams where combined contribution, collaboration, and results were expected
• Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action
• Must be able to correlate events and determine the action plan required to avoid incidents recurrence and apply them
• Extensive experience in Quality Systems processes
• Good organization and time management skills
• Ability to work in a high paced team environment
• Strong written and verbal skills with proven ability to lead collaborative efforts
• Perform / lead investigations and root cause analyses for Quality Event deviations related to IT systems
• Author / contribute / collate content for applicable Quality Systems records, including Deviations, CAPAs, Change Requests, SOPs, and others as needed
• Provide periodic and ad-hoc status updates for applicable Quality Systems records to site leadership and record owners
• Track timelines for commitments related to applicable Quality Systems records and prioritize work accordingly
• Contribute data for department (IT) metrics reporting linked to regulatory compliance and Quality Events, including Deviations, CAPAs, Change Requests, Training, and completion of applicable procedural requirements
• Partner with Quality, and Business / Technical Owners on continuous improvement efforts to reduce or eliminate adverse trends related to Quality Events impactful to IT
• Perform periodic reviews of applicable SOPs
• Create / revise SOPs as needed
• Support regulatory inspections as needed
• Minimum of a 2 year degree; 4 year degree preferred
- There is no per diem with this position
- There is no relocation budgeted for this position. If this position requires you to relocate you will be responsible for those costs.
- MUST be able to work without sponsorship or VISA transfer for this position.
By partnering with Kelly® Technology, you'll have direct connections to top companies around the globe—giving you the chance to put your tech skills to work on some of today's most intriguing, innovative, and high-visibility projects. In a world where change is the only constant, our unparalleled connections and IT market expertise help you take your skills exactly where you want to go. We're here to help you gain experience, keep learning, and move your career forward.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 (plus, did we mention we provide a ton of benefits). 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a 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 globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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