Located in beautiful San Diego, our company is a growing, state of the art clinical testing laboratory providing drug testing services for physicians nationwide. We offers a competitive salary and benefits, a positive work environment and the opportunity to work with a highly motivated and talented staff.
Title: QA Document Coordinator
Category: Operations – Clinical Laboratory
Description: Summary
The QA Document Coordinator provides support for document control and records management which includes assigning numbers, document change management, routing for review and approval; tracking all stages of routing, approval, distribution, archival of history files, maintenance of documentation and filing of all master documents. Ensure ongoing and timely support of document management, and administrative support of QA tasks including training.
Essential Duties and Responsibilities include the following:
• Responsible for Standard Operating Procedure (SOP) development and updates
• Format and edit documents, including Standard Operating Procedures (SOPs), specifications, controlled forms and policies that support the laboratory operations and comply with GLP and FDA guidelines as applicable and other quality standards
• Provide consistent document format to achieve uniformity of all clinical operations documents
• Tracks, trends and evaluates data and provides detailed reports to management for evaluation
• Strict attention to detail
• Must be flexible, able to multi-task in a fast paced environment, and operate well in a team setting
• Must be able to proof work and identify non-standard format or working, and errors within documents
• Must have the ability to facilitate training sessions; maintains training records
• May schedule and track quality assurance audits and findings; effectively communicate written and oral findings to management
• Perform all responsibilities in accordance with company policies, SOPs and with all regulatory standards and regulations
• Required to follow all safety procedures, policies, precautions, and Quality Assurance
• Other duties as assigned.
Requirements: EDUCATION and/or EXPERIENCE:
Position generally requires a Bachelors degree in Life Sciences or related area, or related experience and/or training.
• Minimum 2 years directly/related experience in an equivalent role within a FDA regulated pharmaceutical or laboratory is required
• Knowledge of document control processes, working with an Electronic Document Management System is a must
• Knowledge of GLP, Quality System Regulations and ISO standards preferred
• Must be highly skilled in Microsoft Office – Word, Outlook, Excel, Access, PowerPoint and experienced with PCs and databases
• Must have excellent communication skills, with the ability to interact appropriately with all levels of management and staff
• Experience working in a high complexity CLIA/CAP environment preferred
CERTIFICATES, LICENSES, REGISTRATIONS
N/A
If you are interested and available, please send your resume, salary history and cover letter immediatley.
NO STAFFING FIRMS!!!!!!
- Location: Rancho Bernardo
- Compensation: DOE
- Principals only. Recruiters, please don't contact this job poster.
- Please, no phone calls about this job!
- Please do not contact job poster about other services, products or commercial interests.