QA Lab Specialist- Montvale NJ 07645
Temporary to hire
The purpose of this position is to ensure all controlled documentation is properly prepared, revised, reviewed, approved, distributed, expired, and retained according to the appropriate procedures and external standards. This position will serve as an Electronic Document Management System (EDMS) administrator and train/qualify internal users.
ESSENTIAL FUNCTIONS AND BASIC DUTIES
SYSTEM MANAGEMENT: 25%
- Review, prepare, execute, approve, assist with, and maintain applicable Change Management and Validation documentation for retrospective, concurrent, and prospective validation compliance specific to EDMS.
- Assist with current and future electronic processes and workflows in the QMS.
- Configure data as EDMS Administrator as required for system updates.
DATA ENTRY & INTEGRITY:
Compose Assessments and Qualification Schemes
Migrate data as required for system updates
Ensure Curriculum Compliance
Configure Data for system updates
DOCUMENT PROCESSING: 20%
- Review change requests and documentation for compliance.
- Process all change requests and documents for review, approval, and issuance.
- Distribute copies of controlled documentation as requested.
- Ensure revision control of all controlled documents.
- Purge obsolete documents per procedure.
CUSTOMER SERVICE: 15%
- Assist internal customers with technical support and status inquiries.
- Provide copies of documentation for internal and external distribution.
- Train organization on the functionality of the electronic document management system.
- Develop Content.
- Maintain all electronic document management system training documentation.
REPORTING & ANALYSIS: 10%
- Create monthly trending reports and metrics for Quality Review Committee (QRC), Quality/Regulatory Management Team (QRMT), and others as appropriate.
- Deliver departmental metrics as requested.
- Analyze and plan upgrade strategies to ensure compliance.
DEPARTMENT/PEOPLE MANAGEMENT: 10%
- Assist with maintaining departmental procedures and processes.
- Assist with management of Document Control department. This includes work assignments, document distribution, and departmental guidance on document control processes.
AUDITS, INSPECTIONS, AND COMMITMENTS: 5%
- Participate in the organization and execution of audits and inspections, including personnel, requests, documentation, and process flow.
- Ensure accurate, thorough, and on-time completion of all Agency and Third-Party Commitments.
- Maintain documentation and records in accordance with regulations and internal policies.
- Act as SME for system inquiries during audits and regulatory inspections.
Bachelor of Science or Bachelor of Arts degree
Proficiency in Microsoft Office Suite, Internet Browsers, and Adobe PDF applications. Learning management system experience is a plus.
4 or more years' experience with Electronic Document Control Systems. Proofreading experience is a plus.
Abilty to prioritize daily workload, multitask, and shift scope to meet business needs. Ability to work independently, cross-funtionally, and within a team environment. Possesses strong written and verbal communication skills. Possesses a strong attention to detail and the ability to troubleshoot complex documentation issues with minimal guidance. Knowledge of Quality Management System structure. Cognizant of applicable ISO and CFR standards/regulations. Ability to participate effectively in audits and inspections. Ability to train and qualify EDMS users. Obtains people management skills and ability to motivate peers.
With Kelly, you'll have access to some of the world's highest regarded scientific organizations—providing you with opportunities to work on today's most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you'll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.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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