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« Back to Search Quality System Administrator
Camarillo, CA

Salary: $ 20.00 per hour
Date Posted: December 31, 2018
Job Type: Temporary to Hire
Job ID: 341950

Job Description

The Quality Administrator supports the daily execution of Quality System processes. This includes Document and Record Control, Change Control, Personnel Training, Deviations, Non-conformance, CAPA, Management Review, Audit.

General Duties and Responsibilities:

  • Administers the Change Control program 
  • Creates/revises Standard Operating Procedures (SOP) and work instructions.
  • Initiates, routes, and implements Change Requests as assigned.
  • Distributes new and updated SOPs, Forms, WIDs
  • Collects superseded and obsoleted SOPs, Forms, WIDs.
  • Coordinates periodic review of SOPs.
  • Maintains, updates, and archives GMP records including batch records, purchase orders, complaint records, training records. 
  • Coordinates archival, retrieval, and destruction of GMP records from off-site storage facility.
  • Supports backroom activities on regulatory and 3rd party inspections
  • Assists with the completion and approval of Deviations and CAPAs.
  • Assists recall activities as assigned.
  • Trains and provides guidance on Quality System processes and related activities
  • Collects and compiles data from various Quality System databases and presents to Operations Management team.
  • Establishes a good quality of work
  • Participates in team meetings and strategy sessions
  • Participates in continuous improvement initiatives

Requirements: 

  • Minimum of 1 year in pharmaceutical operations required.
  • High School Diploma required. Bachelor's degree preferred, health sciences preferred.
  • Internal auditing experience a plus.
  • Working knowledge of FDA GMP regulations and quality system regulations
  • Knowledge of manufacturing processes.
  • Good communication skills at all levels, both written and verbal; both individually and in a group setting.
  • Strong skills in analytical thinking and problem solving.
  • Ability to perform multiple tasks and ability to effectively manage conflict.
  • Ability to work in teams to obtain results. 
  • Must have working knowledge of basic PC software: Excel, MS Word, PowerPoint, etc.