Document Control Specialist

Organization: 
GenMark Diagnostics
Job Location: 
Carlsbad, CA
Job Description: 

Job Title: Document Control Specialist
Department: Quality Assurance
Location: Carlsbad, CA
FLSA Status: Non-exempt

Essential Role and Responsibilities (other duties may be assigned):
The Document Control Specialist, under direction of Document Control Manager, executes activities to maintain integrity of the Quality Management System.
Key Tasks and Responsibilities:
1. Member of a team responsible for coordinating and executing all activities necessary to maintain compliance with GMP and/or ISO 13485 and the integrity of the Quality Management System
2. Maintain controlled copies of Quality documents in the files and in electronic databases
3. Execute document and change control process ensuring accuracy and completeness of documents prior to release
4. Collaborate with other teams in the timely implementation of protocols, reports and other design control and process validation activity.
5. Guide cross-functional teams in good documentation practices
6. Review batch records for completeness and accuracy
7. Support maintenance of design history files, device master records, and technical files
8. Facilitates document retrieval during regulatory inspections
9. Support Operations in Inventory part number control and BOM maintenance as a result of an approved request
10. Support maintaining the Training Program

Requirements: 

Qualifications: To perform this job successfully, an individual must be able to perform each essential responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Proven and effective interpersonal communication skills with a demonstrated ability to interact with internal customers in a positive, friendly, and professional manner.
• Excellent presentation skills and writing skills.
• Adept at influencing, gaining consensus, and capable of overcoming resistance by presenting a powerful case for implementing new initiatives or ideas.
• Proven ability to prioritize responsibilities in a high pressure, dynamic, multitasking environment.
• Experience working in an FDA regulated environment is preferable.
• Extremely organized and detail-oriented.
• Proficient in Microsoft Office, especially Word and Excel, for editing and tracking documents.
• Experience with Document and Change Control electronic systems
• Experience with Master Control a plus.
• Experience with ERP system a plus.
Education requirements: minimum HS +2 year field experience

Contact Information: 

To Apply:
Please email your resume to careers@genmarkdx.com and include the Job Title in the subject line of your email.

About Our Organization: 

GenMark Diagnostics (NASDAQ: GNMK) is a leading provider of automated, multiplex molecular diagnostic testing systems that detect and measure DNA and RNA targets to diagnose disease and optimize patient treatment. The company's eSensor® XT-8 system supports a broad range of molecular diagnostic tests with a compact, easy-to-use workstation and self-contained, disposable test cartridges. GenMark has a number of FDA cleared tests for IVD use, including a Cystic Fibrosis Genotyping Test, Warfarin Sensitivity Test, and Thrombophilia Risk Test. The company also has a Respiratory Viral Panel (RVP) test in clinical trials and tests for HCV Genotyping, 2C19, and KRAS in development.

AN EQUAL OPPORTUNITY EMPLOYER
All employment decisions are made without regard to race, color, religion, sex, sexual orientation, national origin, age, creed, ancestry, marital status, non-job-related handicap or disability, veteran status, or any other legally protected status.