Document Control Specialist

Industry

Manufacturing and Production

Advert ID

USA_553431

Location

Livermore

Job Type

Contract

Hours

Full-Time

Salary Range

Up to USD31.25/hr

No. of Openings

1

Branch Information

Stockton, CA - (USA) 3558 Deer Park Drive Suite 102 CA Stockton , CA 95219 Phone : 209-239-0367

ContactNumber

209-239-0367

Job Description

Quality Analyst Document Control Specialist - $31.25



Responsibilities

-Independently manage and monitor the processing, review, and approval of all controlled documents in document management systems (DMS) and supporting manual systems.

-Develops and reports document control key performance indicator metrics and change management statistical information to management team as required.

-Manages GMP records for cataloging, archival, retrieval and scheduled destruction of records in accordance with established procedures.

-Commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.

-Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities

-Coordinate the revision process of Standard Operating Procedures (SOPs), forms, and other controlled documents assuring that the corporate and regulatory standards are upheld

-Manage the daily flow and final release of controlled documents through the document management system.

-Participates in the development and roll-out of document control tools, monitors documentation/Quality Systems function, and coordinates with IT on issues

-Develops and delivers training regarding document control processes and system changes

-Maintain master documents and records (both hardcopy and/or electronic) to ensure documentation is retrievable and files are accurate, complete, and well organized



Qualifications

Bachelor's degree in scientific discipline preferably Life Sciences, but not required

Minimum of two (2) Plus years QA document control experience

Experience in Document Control System and network-based Quality Management Systems

Worked in an FDA regulated environment

Working knowledge of ICH/GMP regulations and expectations

Proficient in document management systems

Highly Proficient in Word, Excel, and PowerPoint - Smartsheet and SharePoint are a plus