Document Control Specialist Job in Carlsbad 92008, California US
Job Title: Document Control Specialist
Department: Quality Assurance
Location: Carlsbad, CA
Company Mission: GenMark Dx’s mission is to become the market leader in providing high value, simple to perform, clinically relevant multiplexed molecular tests to aid in the diagnosis of disease and the selection and dosing of therapies. GenMark Dx’s proprietary eSensor® technology is based on the principles of competitive DNA hybridization and electrochemical detection. Our eSensor® technology is highly specific for the target biomarker and is not based on fluorescent or optical detection. As a result, our diagnostic tests are less prone to sample contamination risk and do not require many of the time-consuming washing and preparation steps required by competing multiplexing technologies.
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
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, multi-tasking 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.
Education requirements: minimum HS +2 year field experience
Language Skills: Must be proficient in writing, and communicating in the English language.
Reasoning Ability: Strong problem solving, judgment and decision making skill are required.
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.