Document Control Specialist in San Diego, CA at Volt

Date Posted: 6/26/2020

Job Snapshot

Job Description

Position Summary

Manage document control activities, including but not limited to, change control, training, and maintenance of documents. Track, scan, archive, and manage quality controlled documents and quality records, including training records, forms, specifications and batch records.

Essential Functions

  • Manage document control, change control and training processes for GxP activities
  • Prepare and handle documents and procedures for review, approval, and execution
  • Develop, review and revise documentation procedures
  • Establish and maintain records management process including scan, storage, archival and retention
  • Handle and track change control activities and ensure timely approval and closure
  • Oversee on boarding and on-going training program, tracking and maintaining training records
  • Perform other duties, as assigned

Qualifications

Education & Experience:

  • Minimum, Bachelor’s Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.)
  • Minimum, 4 years of relevant bio-pharmaceutical industry experience, with a minimum 2 years of document management role

Knowledge and Competencies:

  • Knowledge of GMP and GDP regulatory requirements
  • Self-motivated, excellent organizational skills, and ability to prioritize effectively
  • Ability to work and make decisions independently and as part of a team
  • Strong and effective verbal, interpersonal, and written communication skills
  • Strong collaboration, strategic thinking, leadership, and teamwork skills
  • Advanced computer skills
  • Preference- EDMS experience

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear.  The employee frequently is required to use hands to finger, handle, or feel.  The employee is occasionally required to stand, walk, and reach with hands and arms.  The employee must occasionally lift and/or move up to 10 pounds.  Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.

Work Environment

The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate.

This position requires working with biological and/or chemical hazards

Volt is an equal opportunity employer