Document Control Specialist


Description/Functions:

  • This position is an active member of Full Spectrum Group’s Quality Management System.
  • This position is responsible for the control of documentation, managing QMS training, and processing 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 updates QMS training files/database 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) is 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.

About Full Spectrum Group:

Full Spectrum Group (FSG) is a dynamic company consisting of veteran service engineers, software specialists, and application chemists. FSG specializes in the service, repair, and validation of a wide range of instrumentation including Gas, Liquid, and Ion Chromatography Systems, Mass Spectrometers, Purge-and-Trap, Headspace Units, and Total Organic Carbon Analyzers.

Over the past 25+ years, FSG has worked with many Manufacturers and Distributors to assist with their service needs. The Full Spectrum Group service team consists of individuals with diverse backgrounds relating to analytical instrumentation, many of them being former service representatives for the manufacturer or product development managers. New employees undergo an extensive in-house training program in addition to attending manufacturers’ training courses.

Full Spectrum Group is an ISO 9001:2015 & ISO/IEC 17025:2005 accredited organization. These standards require a comprehensive quality management system that includes a company-wide commitment to outstanding customer satisfaction, traceable documentation, organizational planning, and continually improving quality standards.

As we continue to improve our quality system with these global standards, we believe that our decision to become ISO Certified is a proactive one that anticipates our customers’ demands and demonstrates our dedication to providing superior laboratory support and services to all our customers.

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