Quality Assurance Specialist-Houston, TX
Kelly Scientific Resources is currently seeking a Quality Assurance Specialist for one of our top clients in Houston, TX.
As a Quality Assurance Specialist you will be responsible for verifying the customer's compliance with ISO/cGMP quality system requirements.
Responsibilities include, but are not limited to:
- Provide immediate support to operations and quality control staff to address compliance related concerns (QA on-the-floor support).
- Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams.
- Audit internal quality system elements in manufacturing and operational support areas.
- Provide oversight for compliance of Change Controls, CAPA and investigations, OOS and deviations. Perform external audits of suppliers/vendors/off-site facilities.
- Act as a customer interface during on-site audits, conference calls and other standard means of communication.
- Independently identify and manage special projects or QA compliance functions as agreed upon with QA management.
- Prioritize and manage a variety of projects simultaneously. May need to lead and direct the work of others.
- Review and approve validation documents. Review and Master Batch Records (MBR) and supporting documents.
- Perform review/release of batch records, as needed.
- Bachelor's degree in the Life Sciences with 1-3 years of relevant work experience
- Direct QA commercial drug substance/drug product experience required or an equivalent amount of aseptic processing and cell therapy manufacturing experience.
- GMP compliance and Part 11 compliance knowledge preferred.
- Experience with oversight of aseptic processing and the associated international aseptic processing regulations.
- Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast-paced environment; team oriented; independent work skills and a strong work ethic.
- The ability to interface and communicate directly with clients is required.
- Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.
This is a temp opportunity with the possibility to become permanent. Pay rate will be dependent upon level of education and experience. If you meet the above qualifications, please submit your resume for immediate consideration.
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.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. 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.]] 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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