Document Control Coordinator
Location: Santa Rosa, CA
Type: Full-Time, Temporary
Full-time contract Document Control Coordinator needed in Santa Rosa to maintain records management for Quality Systems and is responsible for backup support for Document Control. Pays $17/Hr.
Duties:- Tracks training compliance and reports status of company-wide training compliance.
- Coordinates training compliance for satellite employees.
- Enters training records into the Process Instruction training database. Create individual employee files and sort and file training records. Investigate and respond to training-related inquiries.
- Accurately receives, sorts, logs, files, and checks out / checks in production lot history records, data sheets, and equipment asset files.
- Maintains recent records in filing cabinets. Transfer old records to boxes; label and relocate to long-term storage shelving.
- Processes protocols and reports, scans and uploads document to MasterControl.
- Supports user requests for documentation and updates satellite areas within facility. Supports controlled copies distribution/retrieval.
- Orders external standards, maintains tracking system and coordinates review with users.
- Maintains records in the document control storage room and long term storage area in a state of audit readiness ensuring timely retrieval and efficient access to quality system and production information.
- Retrieve quality records requested during an internal and/or external audit.
- Issues, scans, and archives engineering builds and laboratory notebooks.
- Responsible for providing backup support for coordinating document change orders (DCO), coordinates review and approval.
- Responsible for the retention of Risk Management documents.
- Performs filing and scanning of quality system documentation.
- Provides instruction to employees, as needed, to promote compliance with the various requirements of Document Control.
Requirements:
- Knowledge of ISO and GMP regulations desired.
- Knowledge of documentation control requirements for medical device manufacturing to meet FDA and ISO 13485 regulations desired.
- Must be detail-oriented and possess strong organizational and time management skills with the ability to prioritize and manage completion of multiple tasks/projects with company personnel.
- Strong interpersonal skills, with the ability to communicate effectively with all levels of staff including nontechnical and technical personnel.
- Must be quality oriented and willing to promote quality standards.
Minimum Education: High school diploma required
Certified Employment Group is one of Northern California's largest, privately owned staffing firms. Serving Northern California since 1963, Certified has spent over 50 years building a solid reputation for providing reliable, skilled staff to a wide range of industries. Certified specializes in temporary, temp to hire, and direct placements. For up to date job openings, follow us on Facebook and LinkedIn or visit our website at www.certifiedemployment.com.
To apply for this position, please click apply or submit your resume and cover letter as a word doc to srbr@certifiedemployment.com and put Document Control Coordinator 14361 on the subject line.