Document Control Administrator, Biotech
Do you have experience in Document Control and strong with attention to detail? Our client is seeking a highly organized self-starter to join their innovative company in San Diego, CA.
The Quality Assurance, Documentation Control Administrator will perform duties related to electronic Quality Management Systems (eQMS),documentation control, and training supporting Client's Quality Management System. This position will be responsible for managing Quality System documents while ensuring their accuracy, quality, and integrity.
- Provide support to maintain the Quality Management System following 21 CFR 117, 21 CFR 123, and SQF requirements
- Serve as a critical team member for implementing Client's eQMS
- Assist with training and coaching Client employees on the Document Control System, including document approval workflow, templates, and format
- Work with Client's departments to generate new and revise existing documents by assigning document numbers or revisions, assisting with formatting, routing documents for approval, and filing approved documents following document control procedures
- Maintain and facilitate the Document Control System and related procedures
- Support the training program, including assisting with training plans, reporting, and scheduling training sessions
- Support the collection, maintenance, and storage of Quality System records, including supplier documents, verification and validation records, production batch records, test records, and other FSMA related documentation.
- Assist in audits and publish audit reports (Internal and External)
- Provide administrative support within the Quality Assurance Department
- Assist QA management with special projects or other duties as assigned
- Working knowledge of Good Documentation Practices for regulated industry.
- Strong proficiency with computer systems, including eQMS system, and MS Office suite, particularly Word, Excel, and PowerPoint.
- Strong organization skills, with the ability to organize, plan, prioritize work, and manage multiple projects effectively, within agreed upon timelines.
- Strong interpersonal skills, with the ability to positively interface with individuals at all levels of the organization.
- Strong professional communication skills, including written, verbal, and presentation.
- Strong team orientation, with the ability to self-start, as well as work independently.
- Strong attention to detail with the ability to perform tasks with a high degree of accuracy.
Qualifications & Experience:
- Relevant work experience in Quality Assurance or Document Control in FDA regulated industry
- Experience in implementing, administrating, and supporting eQMS highly preferred
- Expertise with Microsoft Word, Excel, Adobe Acrobat, and PowerPoint, to perform critical job functions and trending and reporting.
Apply today for immediate consideration! If you're unable to apply through the website, please email resumes and position title to JEND557@kellyscientific.com.
Kelly Science & Clinical is the premier destination for Scientific Professionals seeking Direct-Hire, Temp-to-Hire, and Contract positions across the country. Scientific Recruiters are ready to select and represent the best candidates to join their award winning bio-pharmaceutical clients.
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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, 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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