Document Control Specialist in San Leandro, CA at Apex Life Sciences

Date Posted: 5/10/2018

Job Snapshot

Job Description


Position Summary: Responsible for managing company documents while also ensuring their accuracy, quality and integrity. Help our client to adhere to record retention policies to safeguard information and retrieve data more effectively.

Essential Functions:


• Store, manage and track company documents.


• Scan, image, organize, maintain documents, and archive inactive documents and records in accordance with client’s record retention procedures.


• Process Engineering Change Orders (ECO’s), while trending and tracking that process.


• Provides Internal and External audit support.


• Track and control training records


• Performs daily job functions under minimal supervision.


• Perform administrative tasks as needed.


• Identifies and evaluates possible system improvements, performs system user acceptance testing of new functionality. Participates in release projects including training.


• Excellent written and verbal communication skills.


• Ability to build and nurture strong, positive relationships with cross-functional teams.


• Demonstrates understanding of regulatory requirements that impact Quality Systems.


• Serve as compliance SME with regard to Change Control.


• Perform incoming inspections as needed.

QUALIFICATIONS:


• Requires a basic understanding of cGMP (Current Good Manufacturing Practices) and ISO13485.


• BA/BS Degree or equivalent, plus a minimum of 3 years prior experience in a regulated industry (Pharmaceutical, Medical Devices, or Diagnostics) in a Quality, Quality Systems, Compliance, Supply Chain Management or related field is required.


• Good math and verbal/written communications skills. Computer literacy is required. Experience with Expandable is a plus.