The Document Control Clerk processes changes in the electronic document control system and provides administrative support for Document Control, Quality and Engineering departments. This position will support future growth within the Manufacturing, Engineering and Quality departments.
(Please specify % amount against each responsibility)
(30%) Provide timely and accurate processing of changes, including data entry, copying and filing for electronic document systems. Eliminate backlogs. Ensure approved data management is entered accurately in production management system in relation to electronic document control system (new releases, changes, and obsolescence) and master data inputs.
(15%) Assist in the preparation and coordination of internal and external audits to international and US standards and quality policies and procedures.
(15%) Provide training data entry and documentation for new and existing employees of quality systems training. Assist in the development and presentation of quality systems training documents (Courses, User Guides, etc.)
(15%) Assure compliance to US and international regulations (including but not limited to cGMPs; ISO 13485; Japan, Brazil, Canada, Australia and US country-specific regulations)
(10%) Assist with software validation activities for new or update of electronic systems.
(5%) Assist in the preparation of Quality Systems metrics for Management Review meetings.
(5%) Maintain record retention program (archiving / retrieval) for quality documentation.
(5%) Assist in other responsibilities requested by management to ensure compliance.
Location: Menlo Park, CA
Minimum high school diploma required.
At least two years of experience in an administrative role. Medical device, drug, or similar regulated industry experience preferred.
Must have effective written / oral, interpersonal, organizational skills. Knowledge of MS Office, Excel, and using web-based applications.
Must be able to provide and implement solutions to quality problems. Requires the ability to understand the impact of country-specific cGMPs, ISO 13485, and EU MDR requirements on document control.
Nesco Resource and affiliates (Lehigh G.I.T Inc, and Callos Resource, LLC) is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.
Document Management Systems