Document Control Specialist


 

Description/Functions:

  • This position is an active member of Full Spectrum Group’s Quality Management System.
  • This position is responsible for control of documentation, managing QMS training, and processing of document requests.
  • Ensures that appropriate document approvals are obtained prior to documentation becoming effective and/or released.
  • Proficient understanding and working knowledge of processes, procedures, and systems used in quality management systems.
  • Organizes and update QMS training files/data base to maintain compliance.
  • Leads process improvement projects related to document control systems, documentation processes and efficiencies.
  • Ensures that work is being performed in accordance with documented procedures, industry standards, and regulatory requirements.
  • Remains well prepared for audits by external agencies/organizations.
  • Perform other duties as assigned.

Essential Functions:

  • Establishes and maintains a document control system for QC procedures, work instructions and forms.
  • Performs periodic internal document control system reviews and audits.
  • Designs, develops, implements, and enforces best practices, processes, guidelines, systems, and technologies to support and enhance the document control function.
  • Maintain Standard Operating Procedures (SOPs) and ensure their compliance to ISO 9001/17025 requirements and the business’ policies.
  • Audits existing procedures and revises as needed. Implements through training.
  • Keeps abreast of ISO changes & enhancements related to document control best practices.

Qualifications:

  • Minimum 3 year’s experience in Document Control in an ISO 9001 certified organization
  • Working knowledge of ISO 9001 Quality Procedures.
  • Recent experience facilitating ISO 9001 audits.
  • Detail-oriented with the ability to multitask in a fast-paced environment.
  • Excellent communication skills. Demonstrated ability to articulate ideas clearly and concisely in verbal and written form.
  • Experience with current Good Manufacturing Practices (cGMP) a plus.
  • Experience integrating acquired companies into an ISO certified organization.

Travel Requirements:

  • Occasional travel to company facilities

Education/Training:

  • Bachelor’s degree in science (chemistry, analytical chemistry biochemistry, biotechnology or similar) or equivalent lab experience.
  • Experienced with Quality System Processes, change control procedures and document change orders required.
  • Knowledge of lab practices, standard concepts, and test procedures for analytical instruments.
  • MS office skills required.
  • Ability to lift 50 pounds.

Interested parties should send their resume and cover letter to [email protected]